MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that the connection between the top of the filter and the blue tubing of a prismaflex m150 disconnected which resulted in a saline leak.This issue was observed while priming prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak testing was performed and no leak or air intake was detected during the priming test.No leak, no crack detected on the three pod membranes and connections.The reported condition was not verified.The cause of the condition could not be determined.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 M150
• 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: 13115303
• MDR Text Key: 283516530
• Report Number: 8010182-2021-00434
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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: 03/31/2023
• Device Catalogue Number: 109990
• Device Lot Number: 21D0204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/27/2022
• 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: Unknown
• Patient Sequence Number: 1