MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (TPE); SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Catalog Number 107144

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  malfunction  

Event Description

It was reported an external fluid and blood leak were observed originating from the venous return line of a prismaflex tpe2000 set.Initially it was solution leaking and later blood content was leaking at the start of therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic sample, the leak could not be 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.

• Brand Name: PRISMAFLEX SETS (TPE)
• 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 Key: 17125727
• MDR Text Key: 317359564
• Report Number: 8010182-2023-00215
• Device Sequence Number: 1
• Product Code: MDP
• UDI-Device Identifier: 07332414069339
• UDI-Public: (01)07332414069339
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107144
• Device Lot Number: 23A0118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1