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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
Device Problem False Alarm (1013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2020
Event Type  malfunction  
Event Description
Within the first hour of continuous crrt, the loss/gain limit on the was at 160 ml/hr (set to 200 ml/3 hrs) and counting upward. Nothing was touching the scales and the effluent line was adjusted. The effluent scale was calibrated with the assistance of icon representative. Low end of calibration read -4 with upper end
=
3. The numbers were not increasing to reach the loss/gain limit. The patient vital signs and fluid balance remained stable. Over time, the loss/gain limit was not reached and gradually reset to +/-10. Patient treatment was completed. Patient vital signs and fluid loss remained stable. Manufacturer response for crrt pump with effluent scale, (brand not provided) (per site reporter). The calibration of the effluent scale was within standard. Effluent scale alarm is very sensitive, and a false alarm was most likely triggered by vibration of the building, air currents from heating/cooling bents, or other environmental factors.
 
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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 Key10108687
MDR Text Key193374287
Report Number10108687
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 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
Is this a Product Problem Report? Yes
Device Operator
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 FDA05/07/2020
Event Location Hospital
Date Report to Manufacturer06/02/2020
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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