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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS MODULE PUMP ADMINISTRATION; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION CORPORATION ALARIS MODULE PUMP ADMINISTRATION; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2123-0007
Device Problems Leak/Splash (1354); Split (2537); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2014
Event Type  malfunction  
Event Description
Pt's pump was beeping; it appeared to be low battery.Upon plugging it in, however, the pump had a "very low battery" alert.The pt was taken to ct right afterward.Rn powered the pump down-> 5 (to restore) when he got back.When pt returned from ct, the ct tech asked rn to check the pump because the pt heard a popping sound in ct.Ct had used the left antecubital site for dye injection which was where this pump was infusing also.Upon inspection, there was leaking noted from the pump.The tubing was split by the blue piece that comes out of the top of the pump.The pump and tubing where removed from the pt to be replaced.The iv site was not affected and the pt appeared unharmed.
 
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Brand Name
ALARIS MODULE PUMP ADMINISTRATION
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION CORPORATION
3750 torrey view court
san diego CA 92130
MDR Report Key4268327
MDR Text Key5034589
Report Number4268327
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 11/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number2123-0007
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2014
Event Location Hospital
Date Report to Manufacturer11/21/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/07/2014
Patient Sequence Number1
Patient Age91 YR
Patient Weight47
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