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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 2C2063K
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2023
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter address: (b)(6) e1: initial reporter postal code: (b)(6) the device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the bladder of a large volume infusor ruptured which resulted in a leak; further described as "the balloon within the bottle appears to have been leaking.The balloon is misshapen." the was identified toward the end of the 24 hour infusion period.The device was filled with vancomycin (viatris) 4000mg in sodium chloride 0.9%.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H4: device manufacture date: the lot was manufactured from december 1, 2022, to december 5, 2022.H10: the device was received for evaluation.A visual inspection noted that the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality and there were none found on the bladder that may have led to the rupture.The reported condition was verified.The root cause could not be determined; however, a possible root cause for the bladder rupture may be due to inherent variation in the material as bladders are manufactured with rubber.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 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 Key17086661
MDR Text Key316807497
Report Number1416980-2023-02796
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412579412
UDI-Public(01)00085412579412
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
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,Followup
Report Date 07/13/2023
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 Number2C2063K
Device Lot Number22N004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2023
Initial Date FDA Received06/08/2023
Supplement Dates Manufacturer Received07/04/2023
Supplement Dates FDA Received07/13/2023
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 Initial
Patient Sequence Number1
Treatment
SODIUM CHLORIDE 0.9%.; VANCOMYCIN (VIATRIS).
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