MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955595

Device Problem Leak/Splash (1354)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation, however (b)(6) were provided.The visual inspection of the provided (b)(6) observed an external blood leak from the access pod.The cause of the event was supplier 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.

Event Description

It was reported that during treatment with a prismaflex m100 set, an internal blood leak was observed; however, inspection of (b)(6) provided of the reported indicated that a minor external blood leak from the access pressure pod had occured.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12629168
• MDR Text Key: 283312348
• Report Number: 8010182-2021-00311
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 955595
• Device Lot Number: 21C2405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.