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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 2C1071KJP
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that an infusor was leaking.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.
 
Manufacturer Narrative
(b)(4).The lot 14f005 was manufactured june 5, 2014 - june 6, 2014.The device was received for evaluation.Visual inspection on the device (via the naked eye) noted fluid inside the package that contained the device.When the device was removed from the packaging, the cause of fluid inside the package was visually identified to be an untightened blue winged luer cap.A functional testing was performed by filling the device with green colored water.After filling the device with the green water solution, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The device was monitored until the next day; as a result there were no signs of leak observed.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.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 Key4376182
MDR Text Key5260014
Report Number1416980-2014-48189
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 Date06/01/2019
Device Catalogue Number2C1071KJP
Device Lot Number14F005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/09/2015
Initial Date FDA Received12/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/06/2015
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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