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

Catalog Number 115307

Device Problems Fluid/Blood Leak (1250); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that an external fluid leakage was observed originating from ¿the tube at the artery¿ of a prismaflex m150 set during priming.There was no patient involvement.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

The device was received for evaluation.Visual inspection revealed all the pump segments are disconnected from the support plate.There are no marks of solvent on the tubing.The reported condition was verified.During evaluation, it was noted the involved pump segments of tubing were not bonded to the support plates of the prismaflex set and showed very little to no trace of solvent used to achieve this bonding which is the cause of the event.The pump segment of tubing could remain in place in the sockets on the support place due to the friction between the tubing and the socket since the outer diameter of the tubing is of similar size as the socket.This allowed the defect to remain undetected at the integrity test performed on each set during assembly.However, this friction is not enough for the pump segment of tubing to remain connected to the support plate once the set is loaded on a prismaflex or prismax monitor, and the monitor¿s pump rotors apply pressure on the tubing.A nonconformance has been opened to address this issue.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(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: 17378960
• MDR Text Key: 319623049
• Report Number: 8010182-2023-00273
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414118365
• UDI-Public: (01)07332414118365
• 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: 08/22/2023

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: 115307
• Device Lot Number: 22J0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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