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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

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BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C1073KJP
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was manufactured july 10, 2014-july 11, 2014.The device was recieved for evaluation.Visual inspection revealed a solid white fragment of the duckbill valve component approximately 1.30mm in size, floating in the fluid of the reservoir.The particle was identified to be polyisoprene material via ft-ir spectrophotometer scanning, which is the material of the duckbill valve.The reported problem was verified.The cause of the problem could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
During product evaluation, it was identified that there were solid white particles floating in the bladder of a half day infusor.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INFUSOR
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
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4376322
MDR Text Key12907520
Report Number1416980-2014-48213
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K062457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/08/2014
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
Device Expiration Date07/01/2019
Device Catalogue Number2C1073KJP
Device Lot Number14G020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2015
Initial Date FDA Received12/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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