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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand NamePRISMAFLEX M100
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key13118249
MDR Text Key283139067
Report NumberMW5106370
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number2010406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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