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U.S. Department of Health and Human Services

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

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GAMBRO AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PHOENIX
Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2020
Event Type  malfunction  
Event Description
We could not give patient rinseback due to malfunction of machine. Machine went into alarm and generate safe state displayed on screen. Later after trying turning machine back on to try and rinse machine displayed "dialysate line connector error". Work order was submitted, and bio-med contacted. Manufacturer response for hemodialysis unit, gambro (per site reporter). Manufacturer technician stated that he would let the quality department know, but unsure if they would do anything about it.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO AB
one baxter parkway
deerfield IL 60015
MDR Report Key10017080
MDR Text Key189588919
Report Number10017080
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 Biomedical Engineer
Type of Report Initial
Report Date 04/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPHOENIX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/01/2020
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

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