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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 2C2702K
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the bladder of two (2) small volume infusors burst.This issue was discovered during filling.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Initial reporter city: (b)(6).Initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H4: the lot was manufactured from july 16, 2020, to july 17, 2020.H10: the device was received for evaluation.A visual inspection with the naked eye was performed which noted that the bladder had been ruptured.The reported condition was verified.The ruptured bladder was examined for the following signs of abnormality.There were no signs of abnormality found on the bladder that may have led to the rupture.The cause of the condition could not be determined; however, possible root cause for the bladder rupture may be due to inherent variation in the material, as bladders were 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 Key16481368
MDR Text Key310775819
Report Number1416980-2023-00826
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412579368
UDI-Public(01)00085412579368
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/06/2023
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 Number2C2702K
Device Lot Number20G012
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/08/2023
Initial Date FDA Received03/03/2023
Supplement Dates Manufacturer Received04/04/2023
Supplement Dates FDA Received04/06/2023
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
NA.
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