PRISMAFLEX 60230114700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-02 for PRISMAFLEX 60230114700 manufactured by Gambro Renal Products, Inc..

Event Text Entries

[18163519] This event involved what the manufacturer referred to as a history jump, which involved some errors and subsequent erroneous volume readings. The nurse had changed the patient set and got a clamped bag alarm and a bag weight alarm shortly thereafter. The history logged in the machine confirmed this. The machine continuously takes weight readings on all bags and gives flow readings and volume readings that directly correlate to those weight readings. Nursing education was called to the machine and saw that patient's fluid removal readings were far beyond acceptable parameters. The machine was shut down. She checked the patient vitals and that check showed that the patient showed no ill effects from the false fluid removal readings. The machine was removed from service and we were called to check the machine. We called the manufacturer. The service representative showed the next day to calibrate the scales and we reviewed the event history logs. The history shows that the flow and volume readings were progressing at acceptable rates until the clamped bag alarmed at 5:59 am and the bag weight alarmed at 6:00 am. The readings at 6:00 showed sharp spikes. At 6:01 the readings were on there way back to normal and were completely normal by 6:03 am. We were able to reproduce several history jumps, bag alarms and associated spike flows and volumes by simply lifting the bottom of the bag while the machine is running. It took four seconds of contact with the bag to produce an alarm. The manufacturer said they have had previous history jumps and were working on the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number710270
MDR Report Key710270
Date Received2006-05-02
Date of Report2006-05-01
Date of Event2006-04-24
Report Date2006-05-01
Date Reported to FDA2006-05-02
Date Added to Maude2006-05-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRISMAFLEX
Generic NameDIALYSIS MACHINE, CVVH
Product CodeKPF
Date Received2006-05-02
Model NumberPRISMAFLEX
Catalog Number60230114700
Lot Number*
ID Number*
Device AvailabilityY
Device Age4 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key699318
ManufacturerGAMBRO RENAL PRODUCTS, INC.
Manufacturer Address10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-05-02

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