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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE2000 SET; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE2000 SET; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA Back to Search Results
Catalog Number 107144
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external fluid leak was observed from an unspecified area of a prismaflex tpe2000 set prior to use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received, and a video of the sample was provided for evaluation.Visual inspection of the video showed a leak at the level of the effluent port.Visual inspection of the actual sample did not identify any abnormalities that could have contributed to the reported condition.Functional air leak testing was performed (pressure 2 bar), and the leak was confirmed originating from a crack in the effluent port.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the crack was determined to be related to mechanical shock applied to the product during shipping, transport, and/or improper storage.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX TPE2000 SET
Type of Device
SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR   69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key18914188
MDR Text Key337784225
Report Number8010182-2024-00098
Device Sequence Number1
Product Code MDP
UDI-Device Identifier07332414069339
UDI-Public(01)07332414069339
Combination Product (y/n)N
Reporter Country CodeNO
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 Nurse Practitioner
Type of Report Initial,Followup
Report Date 04/11/2024
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 Number107144
Device Lot Number23E0109
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/15/2024
Supplement Dates Manufacturer Received04/05/2024
Supplement Dates FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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