U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
데이터 추가 비고
Pump, infusion - Product Code FRN
원인
Frequent proximal occlusion alarms (poas) occurring on symbiq devices with list numbers 16026 and 16027. when there are false alarms, the pump will continue to alarm even though there is no occlusion present. false poas could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
조치
Hospira sent letters on May 2, 2013, to customers informing them of the discontinuation of sales, service, and support for the Symbiq pump were sent via traceable mailing to all affected customers. For questions regarding this recall call 224-212-4892.
Worldwide Distribution - US (nationwide) and Canada
제품 설명
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. || The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.