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ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS

Notice type: Advisory

Date: 27/03/2013

  

Product name or type:
ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS

Reference:
SN2013(03)

Manufacturer Or Supplier:
Hospira Inc.

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Clinical Engineers 
Nursing Managers 
Nursing staff 
Purchasing Managers 
Hospital personnel 
Palliative Care Units 
Intensive Care Units 
Anaesthetic Officers 
Accident & Emergency Departments 
Adult intensive care units 
Day surgery units 
Oncology units 
Paediatric intensive care units 
Neonatal units 
Theatres 
All wards

Problem Or Issue:
Hospira has circulated six (6) Field Safety Notices (FSNs), since August 2011, advising of various issues relating to the GemStar family of infusers which could result in overdose, under-dose or a delay/interruption in therapy.

Background Information Or Related Documents:
The manufacturer, Hospira, in agreement with the IMB recently circulated a Caution in Use FSN providing a summary of the six FSNs relating to the GemStar family of infusers issued by Hospira since August 2011. This Caution in Use FSN was circulated to assist users in the management of all issues identified and to ensure the safe and effective use of these infusion devices. 

The supply of all new GemStar pumps into Ireland and the EU has been suspended for an initial period of ninety (90) days from the 28th February 2013 due to the number of current FSNs and the recent temporary suspension of their Infusion Pump CE Certification. 

The manufacturer confirmed that consumables and other infusion pump accessories that are necessary for the continued use, repair, and service of these devices are still available for customers.

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS Document

Actions To Be Taken:
1. Ensure that the appropriate personnel are made aware of this notice and the attached Caution in Use FSN. 

2. Identify affected pumps. 

3. Hospira has implemented the following Restriction for Use into clinical practice for the GemStar Infusion Pumps: 

- Do not use on all neonatal populations and infants up to two (2) years of age. 
- Do not use on any patients where therapy is delivered at flow rates 2.0ml/hr or less. 

4. The manufacturer and the IMB advise users to weigh the risk/benefit to patients associated with the use of these devices when administering critical therapies. 

5. Customers should consider the use of an alternative pump, particularly in patients in which an overdose, under-dose or delay/interruption in therapy could compromise patient safety. 

6. Follow the manufacturer’s recommendations in the attached Caution in Use FSN.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Hospira Sligo 
Finisklin Business & 
Technology Park 
Sligo 
Ireland 

Telephone: + 44 1926 834435 
Fax: + 44 1926 834446 
E-mail: rita.wright@hospira.com

All incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-676 4971 
Fax: +353-1-634 4033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie

Please click here to view a pdf version of this Safety Notice

Please click here to view a pdf version of the Field Safety Notice

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