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U.S. Department of Health and Human Services

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

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GAMBRO INDUSTRIES PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M100
Device Problems Computer Software Problem (1112); Failure to Prime (1492)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
Prismax machine unable to recognize m-100 filter set. Was unable to prime the filter set.
 
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Brand NamePRISMAFLEX SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
one baxter parkway
deerfield IL 60015
MDR Report Key10704072
MDR Text Key212131058
Report Number10704072
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 09/28/2020,09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM100
Device Catalogue Number106697
Device Lot Number20E2203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/28/2020
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer10/20/2020
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 Unkown

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