Supply Disruption Alert

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1 Supply Disruption Alert SDA/2016/001 Issued: 9 th February 2016 at 10:00 Valid until: Further Notice Baxter IV Administration Sets Supply Disruption Summary Baxter IV Administration sets (Colleague pump compatible and gravity) will be subject to limited availability across the product range until May 2016 with the potential for impact on the delivery of life saving care Action Action, to be taken by organisations that use these devices Baxter Colleague ( One Set System ) pump compatible IV administration sets 1) Colleague ( One Set System ) IV administration sets should only be used for pumped infusions through a colleague pump, NOT gravity infusions. 2) Identify a procurement lead to manage and co-ordinate the procurement and materials management response, and put in place systems for the close monitoring of demand, inventory levels, and requisitions. 3) An assessment is undertaken into the areas of care that are most dependant on Colleague pump compatible administration sets, and that your organisation s normal suppliers are consulted on further measures you feel will be necessary to mitigate identified risks to patient care and safety. 4) Do not seek to substitute Baxter gravity IV administration sets with products from the Baxter Colleague ( One Set System ) pump compatible range, as this will place additional pressure on already limited stocks, with the potential for the premature non availability of these critical products. 5) Identify and source alternative gravity IV administration sets as necessary to supplement stock of Baxter product. 6) All relevant procurement, materials management and clinical staff should be notified of the supply issue and advice being provided on management of this issue. Where a significant risk to patient safety is identified, resulting from this incident, then your organisation should notify the DH National Supply Disruption Response team at the earliest opportunity to escalate the issue. Contact: Deadlines for actions Actions initiated: Actions completed: 5 days from the date of publication 10 days from the date of publication> Page 1 of 5

2 Product details A list of product lines affected, showing the manufacturer s product code and a short product description is provided in the tables below. Baxter Colleague ( One Set System ) pump compatible IV administration sets Product Code EMC9608 MMC9688L MMC9668L MMC9667L MMC9611L EMC9618 RMC9615 ZMC9625 RMC9604 EMC9603 MMC9609L EMC9601N VMC9627 Description Pump/gravity solution administration set, non-vented, 15µm filter, Y-injection site, basic male Luer Pump/gravity solution administration set, non-vented, 15µm filter, Y-injection site, Clickluer rotary connector with Safeprime cap, Line Label Pump/gravity solution administration set, non-vented, 15µm filter, back check valve, 2 x Clearlink Y-site, Clickluer rotary connector with Safeprime cap, Line Label Pump/gravity solution administration set, non-vented, 15µm filter, Clearlink Y-site, Clickluer rotary connector with Safeprime cap, Line Label Pump/gravity solution administration set, vented, 15µm filter, Y-injection site, Clickluer rotary connector with Safeprime cap, Line Label Pump/gravity solution administration set, vented, no filter, Y-injection site, basic male Luer Pump/gravity solution administration set, vented, 15µm filter, basic male Luer Pump/gravity solution administration set, vented, 15µm filter, basic male Luer, 295cm Pump/gravity dual solution administration set (Continu-Flo), non-vented, 2x 15µm filter, back check valve on primary, Roberts clamp on secondary, Y-injection site, basic male Luer. Supplied with wire hanger Pump/gravity solution administration set, non-vented, 15µm filter, back check valve, 2 x Y- injection site, basic male Luer Pump/gravity blood administration set, flexible double chamber with ball valve, 200µm filter, Clickluer rotary connector with Safeprime cap, Line Label Pump/gravity Buretrol blood administration set, 150 ml burette, flexible double drip chamber, 200µm filter, Y-injection site, Clickluer rotary connector with Safeprime cap Pump/gravity Paclitaxel administration set, vented, non-dehp tube, non-dehp pump tube segment, 0.22µm inline filter, Y-injection site, Clickluer rotary connector & Safeprime cap Product code Description UMC3318 UMC3320 UMC3330 MMC2071b Gravity solution IV admin set, with no Y-injection site Gravity solution IV admin set, with Y-injection site Gravity solution IV admin set, with no Y-injection site and back-check valve Gravity Blood Set double chamber with 4ml tubing Alternative products and suppliers Details of alternative gravity IV administration sets are available through your normal channels of supply or NHS Supply Chain (see contact details below). Your normal supplier, in conjunction with Baxter will manage the allocation of product to where need is greatest and work with you to assess your requirements and to try to provide alternative options to maximise availability of stock. Department of Health Page 2 of 5

3 Problem / background Baxter Healthcare are experiencing problems in the manufacturing process for IV administration products and Urology Irrigation sets (see separate Supply Disruption Alert SDA/2016/002, 9 th February 2016). The Department of Health and NHS England recognise the serious nature of this issue and have initiated a National Supply Disruption Response to co-ordinate remedial action and communications across different areas of the system. Supporting communications are also to be issued in relation to this supply disruption event to Procurement, Pharmacy and Critical Care Networks. Mitigation action is being co-ordinated centrally to try and ensure that suitable alternative products will be available in the event that any product becomes unavailable at any stage, however organisations need to be prepared to adopt alternative products across a number of product lines quickly and safely. Baxter Colleague ( One Set System ) pump compatible IV administration sets Baxter Colleague ( One Set System ) pump compatible IV administration sets present the most significant challenge in terms of product substitution, as only these sets can be used with Baxter Colleague Infusion Pumps. To maintain availability of Baxter Colleague (One Set System ) pump compatible IV administration sets (for fluids and blood lines) during the period of this supply disruption, rationing will be imposed through distribution channels, restricting availability to 85% of normal demand. Maintaining availability of Colleague pump compatible administration sets is being treated as a priority and a number of interventions are being managed centrally to try and ensure continuity of supply across the full range of codes throughout the duration of the supply disruption. The Baxter gravity IV administration sets range (for fluids and blood lines) will be subject severe supply disruption with many products becoming unavailable during February and March A successful outcome is dependent upon the cooperation and support of organisation s in quickly adopting the guidance outlined. Should the recommended actions not be implemented promptly and effectively by all affected organisations, more severe rationing will need to be imposed along with more widespread adoption of alternative Colleague pump compatible product formats. Manufacturer(s) / Supplier(s) details [optional] Baxter Healthcare UK. All enquiries regarding stock requirements and alternative products should be made through the organisation s normal supplier or through the NHS Supply Chain customer services team. Requests for specific technical advice or support with implementing necessary changes should be made via the organisation s Baxter account manager or through the Baxter customer service team: , ask for Jamie Fox or Mandy Lloyd. Department of Health Page 3 of 5

4 Stock and sourcing enquiries NHS Supply Chain Customer Services, dedicated contact; Donna O Rourke. Contact Details or telephone Distribution MHRA NHS England Patient Safety NHS England EPRR Chief Medical Officer NHS England National Clinical Director NHS Supply Chain Wholesalers and Distributors Directors of Procurement Devolved Authorities Medical specialisms Critical care Haematology and oncology Paediatrics Radiology Theatre practitioners If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists. Adult intensive care units All wards Clinical Procurement Specialists EBME departments Emergency Preparedness and Response officer Equipment stores Equipment libraries and stores Intensive care medical staff/paediatrics Intensive care nursing staff (adult) Intensive care nursing staff (paediatric) Intensive care units Intensive care, directors of IV nurse specialists Medical directors Medical libraries Medical oncologists Medical oncology, directors of Oncology nurse specialists Paediatric intensive care units Paediatric medicine, directors of Paediatric nurse specialists Paediatric oncologists Paediatric surgery, directors of Paediatric wards Paediatricians Paediatrics departments Palliative care teams Purchasing managers Department of Health Page 4 of 5

5 Radiation & medical oncology departments Radiation oncologists Radiation oncology, directors of Radiology departments Radiology directors Risk managers Special care baby units Supplies managers Theatre managers Theatre nurses Theatres Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive Supply Disruption Alerts directly from the Department of Health s Central Alerting System (CAS) by sending an to: and requesting this facility. Enquiries England Send enquiries about this notice to the DH Supply Resilience Team, quoting reference number SDA/2016/001 Northern Ireland Enquiries in Northern Ireland should be addressed to: Heath and Social Care Northern Ireland (HSCNI) Sam Blackley, Head of Clinical Procurement Tel: Scotland Enquiries in Scotland should be addressed to: NHS National Services Scotland Wales Enquiries in Wales should be addressed to: NHS Wales Shared Services Partnership Bethan Jenkins Pennaeth Cyrchu Head of Sourcing Partneriaeth Cydwasanaethau GIG Cymru - Gwasanaethau Caffael NHS Wales Shared Services Partnership - Procurement Services Ffon Tel E-bost . WHTN: Addressees may take copies for distribution within their own organisations Department of Health Page 5 of 5

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