BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 2171922 · Received June 29, 2007

    Report

    Report Number
    9616026-2007-00087
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 1, 2007
    Manufacturer
    GAMBRO LUNDIA AB, MONITORS
    Product Code
    KDI
    PMA / PMN Number
    041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCALES WERE REPLACED BUT DID NOT REDUCE THE PROBLEM OF THE WEIGHT CHANGE ALARMS. THE CUSTOMER CONTINUES TO USE THE PRISMAFLEX MACHINE AND THERE HAS BEEN NO REPORT OF ADD'L COMPLAINTS. THE CLINICAL INVESTIGATOR REPORTED THAT FLOOR VIBRATIONS WERE NOTICEABLE IN CERTAIN AREAS OF THE ICU LOCATED ON THE (B)(6) ALSO NOTED HAVING DIFFICULTY CALIBRATING SCALES ON THE (B)(6) BUT ABLE TO DO IT IMMEDIATELY ON (B)(6). ALSO, CONSTRUCTION WAS REPORTED TO BE GOING ON NEXT TO THE HOSP. NO PT INJURY OR ILLNESS REPORTED AS A CONSEQUENCE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    ICU UNIT HAS BEEN USING PRISMAFLEX SINCE (B)(6) 2005. RECENTLY THEY HAD PROBLEMS WITH THE PUMPS THAT COULD NOT BE RESOLVED. (B)(6) 2007-NOTIFICATION OF HARDWARE UPGRADES OF SCALE REPLACEMENT, NEW BLOOD PUMP ROTOR AND MODIFICATION TO HEPARIN SYRINGE PUMP. (B)(6) 2007- PUMP ROTOR AND HEPARIN SYRINGE MODIFICATION INSTALLED. SCALES NOT YET IN. (B)(6) 2007- ALL FIVE PRISMALFEX PUMPS WENT THROUGH REGULARLY SCHEDULED PREVENTATIVE MAINTENANCE CHECKS. BETWEEN (B)(6) AT LEAST THREE OF THE PUMPS WERE USED ON PTS WITHOUT INCIDENT. (B)(6) 2007- THREE PUMPS WERE USED IN THE ATTEMPT TO PROVIDE TREATMENT TO ONE PT. IN ALL THREE CASES, PUMPS ALARMED "CAUTION DIALYSATE WEIGHT" DESPITE TROUBLESHOOTING, THREE PUMPS STOPPED AND TREATMENT WAS DELAYED. BIOMEDICAL TECH CAME IN TO CHECK PUMPS WHICH WERE ALL WITHIN SPECIFICATION WHEN LOOKED AT. THEY WERE REMOVED FROM SVC, RECALIBRATED AND CHECKED AGAIN. (B)(6) - WE AGAIN HAD TWO PUMPS "CAUTION, DIALYSATE WEIGHT" ALARMS. DESPITE TROUBLESHOOTING, CALLED ICON, REMOVED PT AND STARTED TREATMENT ON ANOTHER PUMP. REFERENCE POINTS IN SPECIFICATION. USED THE PUMP OVER A YEAR, AND NOT ONCE HAD WEIGHT CHANGE ALARMS SUFFICIENT TO STOP PUMP. STAFF TRAINED ON USING "CHANGE BAG" SOFT KEY AND PULLING OUT THE SCALES TO CHANGE BAGS. SAME ISSUE HAS OCCURRED MORE THAN ONCE. COSTLY TO PT AND PRESENTS RISK TO PT WITH EXPOSURE TO FOREIGN OBJECT, BLOOD PRODUCTS AND CATHETER MANIPULATION. NEW SCALES ARE ON BACK ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX INTENSIVE CARE HEMODIALYSIS KDI GAMBRO LUNDIA AB, MONITORS PRISMAFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK