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

Catalog Number 106697

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported a medwatch to the fda for this event.Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that nine hours into continuous renal replacement therapy (crrt) using a prismaflex m100, the nurse observed a large amount of bright red blood on the crrt machine and on the floor in front of the machine.The nurse also observed that the tube that connects to the top of the filter was broken off of the prismaflex m100 filter.This was noted to have happened 20 minutes prior to discovery since nurse had been in the room performing other tasks prior.There was also a large amount of air noted in the tubing.Treatment was stopped and the machine was disconnected without blood return.Blood loss was reported to be 150 cc.It was reported that there had not been any significant changes to the settings on the machine or the fluid removal rate from the settings through the entire shift.There was no visible air in the lines closest to the patient.A new filter set was placed and crrt was started without further complications.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 that the return screwed connector was disconnected from the filter resulting in the leakage.The reported condition was verified.The cause of the disconnection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 11344885
• MDR Text Key: 247044537
• Report Number: 8010182-2021-00061
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106697
• Device Lot Number: 20G2202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT
• Patient Age: 35 YR