BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 1787663 · Received August 6, 2010

    Report

    Report Number
    2015691-2010-13848
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. THE TUBING SUPPLIER WAS NOTIFIED OF THE EVALUATION RESULTS. ADDITIONAL CORRECTIVE ACTIONS ARE BEING CONSIDERED AS PART OF EDWARD'S RECEIVING INSPECTION OPERATIONS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORT OF CARD-BOARD LIKE MATERIAL IN THE TUBING WAS CONFIRMED. ONE INFUSION SET WITHOUT ANY ATTACHED COMPONENTS WAS RECEIVED FOR EVALUATION. TWO PIECES OF CARDBOARD LIKE MATERIAL WERE OBSERVED INSIDE THE IV TUBING. THE LARGER PARTICULATE WAS APPROXIMATELY 0.2"-MM X 0.08"-MM AND THE SMALLER ONE WAS APPROXIMATELY 0.1"-MM X 0.08"-MM IN SIZE. THE RETURNED IV SET WAS ATTACHED TO AN UNUSED FLOTRAC KIT FROM THE EDWARDS EVALUATION LAB (CUSTOMER DID NOT RETURN ENTIRE FLOTRAC KIT). AN 18GA NEEDLE FROM THE LAB WAS ATTACHED TO THE DISTAL END OF THE FLOTRAC KIT. THE ENTIRE FLOTRAC KIT AND THE ATTACHED NEEDLE WERE PRIMED/ FLUSHED TO INVESTIGATE IF THE PARTICULATES WOULD FLUSH THROUGH THE TUBING. THE KIT WAS PRIMED AT INITIAL PRESSURE OF APPROXIMATELY 45MMHG (WITH IV BAG HANGING 2 FT FROM TEST BENCH AS RECOMMENDED BY INSTRUCTIONS FOR USE). AT THE END OF THE PRIMING PROCESS THE SMALLER PARTICULATE MOVED THROUGH THE IV LINE AND STUCK AT THE BEGINNING OF THE FAST FLUSH FLOW PATH (INSIDE DPT HOUSING). THE LARGER PARTICULATE ALSO MOVED THROUGH THE IV LINE AND STUCK AT THE BEGINNING OF THE IV MALE CONNECTOR. PRESSURE FROM THE IV BAG WAS INCREASED TO 300MMHG AS RECOMMENDED BY THE IFU. FLUSHING WAS CONTINUOUSLY PERFORMED FOR 2 MINUTES. THE PARTICULATES DID NOT MOVE FURTHER THAN THE PREVIOUSLY DESCRIBED POSITIONS. PER CHEMISTRY ANALYSIS, THE IR SPECTRUM OF THE BROWNS FIBROUS MATERIAL SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLULOSE LIKE MATERIAL. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDER COMPLAINT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT WITH INVESTIGATION RESULTS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND PASSED ALL FINAL INSPECTIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOME CHOICE MACHINE DURING DWELL 2 OF 6. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND THE CAUSE OF THE ALARM WAS UNDETERMINED. THE HP WOULD RESTART THERAPY WITH NEW SUPPLIES AND NOTIFY THE NURSE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNKNOWN MATERIAL WAS FOUND INSIDE THE IV TUBING. THE MATERIAL SEEMED TO BE A MOLD (FUNGUS) OR A PIECE OF CARDBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTRAC SENSOR DISPOSABLE PRESSURE TRANSDUCER DRS EDWARDS LIFESCIENCES DR MHD6S 58840837

    Patients

    Seq Age Sex Outcome Treatment
    1