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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET INTRAVENOUS PUMP TUBING SET

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET INTRAVENOUS PUMP TUBING SET Back to Search Results
Model Number 2425-0500
Event Date 04/28/2010
Event Type  Malfunction  
Event Description

Intravenous secondary bag (piggy back) dose of potassium was hung and programmed to run as secondary at 125 ml/hr. It should have run in over 20 min. Later it was observed that the potassium bag empty. All settings and arrangement of the bags and tubings were correct. On a new iv pump the same was reproduced - the secondary dose ran in wide open even though programmed at slow rate. It was observed that the secondary bag was backing up into the primary iv bag. The pump was tested and found to be functioning correctly. ====================== health professional's impression======================it appeared that the secondary bag solution backed up into the primary bag. ====================== manufacturer response for intravenous pump tubing set, alaris pump module administration set======================"the reported back flow from the secondary to the primary was confirmed. The root cause of the check valve backflow/check valve failure was due to a clear plastic particle found inside the check valve that prevented the silicone diaphram from fully seating against the housing seal area. ".

 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceINTRAVENOUS PUMP TUBING SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key1817141
Report Number1817141
Device Sequence Number1
Product CodeFPA
Report Source User Facility
Type of Report Initial
Report Date 08/02/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number2425-0500
Device Catalogue Number2425-0500
Device LOT Number09115168
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2010
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/04/2010
Device Age1 dy
Event Location Hospital

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