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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO INDUSTRIES PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number REF 95592
Device Problems Insufficient Heating (1287); Improper Flow or Infusion (2954); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Alteration in Body Temperature (4568)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
Patient on continuous renal replacement therapy (crrt). Machine's warming circuit not working during the day, so patient's temp as low as 92 degrees. Id number on machine 38537. Patient ordered for ct so patient needed to get disconnected from crrt (@1600). So, new machine obtained when ready to restart. New machine's warmer also not working, so did not use. (trailed equipment in the hallway. ) sent back to csd. 2nd "new" machine (# 58301) arrived, warmer working. Set up machine and new filter. Started crrt. Then had a flow error for pbp that could not be fixed. I disconnected and reconnected several times, changed the dialysate bag, checked for issues/leaks, etc. Not able to troubleshoot. Treatment stopped. Trailed again on previous machine. Warmer now working. Set up crrt and running w/o issue. But did not restart treatment until 2330 (was off for extended period 2/2 machine issues).
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
one baxter parkway
deerfield IL 60015
MDR Report Key11776234
MDR Text Key249027217
Report Number11776234
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 95592
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Event Location Hospital
Date Report to Manufacturer05/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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