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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 113081
Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)
Patient Problem No Code Available (3191)
Event Date 03/17/2017
Event Type  malfunction  
Event Description
Prismaflex dialysis pump in use for crrt therapy. There were frequent "access pressure too negative " alarms due to patient movement. After several minutes the pump alarmed "access pressure too positive". Nurse attempted to speed up blood flow to get pump to run and to put through self-test to clear alar. She was unable to do either. Pump continued to alarm "access pressure too positive" and then pump froze with alarm screen up. Unable to use touch screen buttons or return blood to patient. Nurse was unable to unload dialysis set from machine due to frozen screen. Customer support was able to talk through issues to unload the set. Existing ways to trouble shoot include self-testing after removing and replacing pod on machine, but this can only be done once before entire set must be taken down. New pump was primed and therapy reinitiated. Patient required blood after treatment. Hemoglobin was at 6. 3 when therapy initiated. Per site reporter: faulty diaphragm in the pressure pod.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO AB
9540 maroon cir fl 4
englewood CO 80112
MDR Report Key6633455
MDR Text Key77313852
Report Number6633455
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 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number113081
Device Catalogue Number113081
Other Device ID NumberDIALYSIS SET 16E2160 EXP 5/1/
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2017
Event Location Hospital
Date Report to Manufacturer04/21/2017
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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