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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 Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2022
Event Type  malfunction  
Event Description
It was reported that the bladder of a large volume infusor ruptured during filling.The set was filled with 0.9% saline solution.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Initial reporter first name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which shows evidence of bladder rupture.The reported condition was verified.The cause of the condition could not be determined; however, the possible root cause for the reported 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 Key15846187
MDR Text Key307310247
Report Number1416980-2022-06410
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412579412
UDI-Public(01)00085412579412
Combination Product (y/n)N
Reporter Country CodeCO
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 12/28/2022
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 Health Professional
Device Catalogue Number2C2063K
Device Lot Number20K057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received12/19/2022
Supplement Dates FDA Received12/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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