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

Catalog Number 955467

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an external fluid leak was observed during the priming of a prismaflex m150 set, due to a damaged effluent bag.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6 and h10 h10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation however, a picture and video were provided.The visual inspection of the provided picture and video observed the presence of a leak at the level of the drain bag.The reported condition was verified.The cause was identified as a supplier issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in mdr follow up #1 is being corrected from blank to 06/22/2021.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11878345
• MDR Text Key: 257385348
• Report Number: 8010182-2021-00176
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123451
• UDI-Public: (01)07332414123451
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 955467
• Device Lot Number: 20H2403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1