• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M60
Device Problems Air Leak (1008); Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
Event Type  malfunction  
Event Description
Priming prismaflex m60 filter for continuous renal replacement therapy (crrt). Filter primed per protocol when circuit connected to patient air pulled into circuit. The system alarmed, the system shut down, and no air was delivered to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INC.
9540 maroon cir
fl 4
englewood CO 80112
MDR Report Key6990145
MDR Text Key90675412
Report Number6990145
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM60
Device Catalogue Number106696
Device Lot Number1610603
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/13/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer10/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-