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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C1009KP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two (2) large volume infusors leaked having the blue winged cap at the end of the tubing.The leaks occurred when the tubing was being filled without the need to open the blue cap.The reported thought the blue caps were not "leak proof." the devices contained normal saline.This occurred prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was manufactured from march 22, 2019 - march 25, 2019.Two (2) devices were received for evaluation.During visual inspection via the naked eye, fluid was observed inside the bag that contained the unit.When the unit was removed from the bag, the cause of fluid inside the bag was visually identified to be untightened blue winged luer cap.Functional testing was performed, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The unit was monitored for twenty-four hours.No signs of leak were observed at the blue winged luer cap of either device.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.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 CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
building 3
irvine CA 92614
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9532914
MDR Text Key173201690
Report Number1416980-2019-07272
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412081373
UDI-Public(01)00085412081373
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K071222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/06/2020
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 Catalogue Number2C1009KP
Device Lot Number19C034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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