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

Catalog Number 955467

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) university.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that as soon as the treatment started with one unit of prismaflex m150 set, an external blood leak was observed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available however, a picture of the sample was provided for evaluation.The visual inspection observed the reported external blood leak from the anticoagulant line connection with the 4 way valves connector of the access line.The reported condition was verified.The cause was supplier related.A batch review was conducted and there was no manufacturing nonconformity recorded regarding this lot number.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
• MDR Report Key: 11068284
• MDR Text Key: 224777208
• Report Number: 8010182-2020-00313
• 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
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 955467
• Device Lot Number: 20C2602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.