BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2448654 · Received February 13, 2012

    Report

    Report Number
    1423500-2012-03439
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THEREFORE, THE SAMPLE WAS NOT REQUESTED AND A BATCH REVIEW WILL NOT BE PERFORMED. THE CYCLER IS STILL USE.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER CONTACTED THE BAXTER TECHNICAL CENTER TO REPORT USE ERROR-FAILED TO FOLLOW THERAPY STEPS. THE REPORTED ISSUE WAS CONFIRMED AND THE ROOT CAUSE WAS USE ERROR. THE LABELING PROVIDED IN THE PATIENT GUIDE WAS FOUND TO BE SUFFICIENT AND ACCESSIBLE TO THE COMPLAINT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING THE HOMECHOICE (HC) NOT WARMING THE BAG DURING USE. THE HOME PATIENT (HP) STATED SHE WAS AT THE END OF THERAPY AND CONNECTED. GTS ASKED THE HP WHERE THE RED CLAMP BAG WAS PLACED AND PER THE HP IT WAS ON THE SIDE AND THE WHITE CLAMP BAG WAS ON THE HEATER PLATE. GTS EXPLAINED TO THE HP THAT THE RED CLAMP BAG ALWAYS GOES ON THE HEATER PLATE AND THE WHITE CLAMP IS THE SUPPLY BAG TO REFILL THE HEATER BAG. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED HOME PATIENT (HP) ON (B)(6) 2012 REGARDING THE REPORT OF HAVING HEATER BAG ON SIDE OF CYCLER AND SUPPLY BAG ON THE HEATER. THE HP REPORTED THAT THE ISSUE WAS RESOLVED, THE HP DID NOT REALIZE THAT THE RED CLAMP BAG HAD TO BE ON THE HEATER. THE HP STATED THAT SHE WAS ABLE TO COMPLETE THERAPY ON THE HOMECHOICE, WITH NO ALARMS. THE HP STATED THAT SHE MAKES SURE THE RED CLAMP BAG IS ON THE HEATER NOW AND HAS NOT REPEATED THAT MISTAKE. PER HP, THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT SHE DISCUSSED THE ISSUE WITH HER NURSE. PER HP, SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR