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

Catalog Number 115307

Device Problem Disconnection (1171)

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

Event Date 02/04/2024

Event Type  malfunction  

Event Description

It was reported that the waste liquid drain bag connector of a prismaflex m150 set "came off" during continuous renal replacement therapy in the intensive care unit.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).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, a video of the sample was provided for evaluation.During visual inspection of the video, it was observed that the stopcock was disconnected from the drain bag.This component was provided by a baxter supplier.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 condition was determined to be related to supplier manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 18761628
• MDR Text Key: 336023165
• Report Number: 8010182-2024-00064
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 03/26/2024

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 Number: 115307
• Device Lot Number: 23E0051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/26/2024
• 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