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

Catalog Number 955467

Device Problem Break (1069)

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

Event Date 03/12/2022

Event Type  malfunction  

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation however photos were provided.Visual inspection allowed to observe that the cone of the access male luer lock (mll) was broken.The reported condition was verified.The cause is a design issue.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a prismaflex m150 set, a flow issue alarm was triggered and a defective return luer connector was observed.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 ; 2242702068
• MDR Report Key: 14279341
• MDR Text Key: 290800496
• Report Number: 8010182-2022-00111
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123451
• UDI-Public: (01)07332414123451
• 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: 05/03/2022

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 955467
• Device Lot Number: 21I0104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/04/2022
• 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.