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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE - IRVINE; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Device Problem Overfill (2404)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that an over infusion was observed in an unknown baxter elastomeric infusion pump.It is unknown whether or not this event occurred during patient use, though no patient injury or medical intervention was reported.No additional information is available.
 
Manufacturer Narrative
(b)(4).A batch review cannot be performed since there was no lot number provided.The sample was not returned for evaluation; therefore, a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue, bldg 3
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue, bldg 3
irvine CA 92614
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3692859
MDR Text Key18310013
Report Number1416980-2014-09406
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/24/2014
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 Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2014
Initial Date FDA Received03/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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