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

Lot Number 2010406

Device Problems Break (1069); Protective Measures Problem (3015); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2021

Event Type  malfunction  

Event Description

The patient's crrt machine alarmed for general system failure and per the instructions on the screen the blood was returned manually with the hand crank.After blood return was complete, the bedside nurse attempted to disconnect the line but met resistance.Another nurse tried as well and they were then able to disconnect the line however the internal part of the return tubing broke off inside the patient's dialysis catheter (return lumen).The line was clamped at the time this happened so no part of the tubing could have entered the patient.The patient's physician was notified immediately and they decided to pull the line.The patient was on an argatroban drip so it was held at this time and the physicians said they would order the line to removed in 2 hours with plans to replace the line overnight.Fda safety report id# (b)(4).

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13118249
• MDR Text Key: 283139067
• Report Number: MW5106370
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2021

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 Lot Number: 2010406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White