MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (M); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955595

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 07/15/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, the leak was observed from the drain bag.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to the bag being reused.The event occurred ¿several hours after treatment started¿.All accessories provided within the set, including drain bag, are single use products.This means that once used, the drain bag must not be reused (i.E., emptied and reused during the same therapy) and should be discarded.The prismaflex control unit operator's manual indicates to ¿change fluid bags when the appropriate caution alarm occurs (pbp bag empty, replacement bag empty, dialysate bag empty or effluent bag full)¿.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.

Event Description

It was reported that an external fluid leak was observed originating from a split in the waste fluid bag of a prismaflex m100 set several hours into continuous renal replacement therapy.The set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX SETS (M)
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 17857652
• MDR Text Key: 324768600
• Report Number: 8010182-2023-00379
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124397
• UDI-Public: (01)07332414124397
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2023

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: Health Professional
• Device Catalogue Number: 955595
• Device Lot Number: 22J0076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2023
• 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
• Treatment: PRISMAFLEX MACHINE