BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3012645 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06670
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). NO ABNORMALITY WAS OBSERVED DURING THE DEVICE HISTORY RECORD REVIEW. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE CAUSE OF THE IIPV-ADULT WAS UNDETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HIGH DRAIN 102 ALARM, ON THE HOMECHOICE (HC) MACHINE, AFTER USE. THIS MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE HOME PATIENT (HP) STATED THAT HE HAD TROUBLE WITH THE HC LAST NIGHT, BUT DID NOT WANT TO SWAP THE DEVICE OUT. THE HP STATED THAT THEY WOULD SPEAK TO THEIR NURSE ABOUT THE EVENT. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THERAPY AND IT STATED ABORTED. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO PATIENT INJURY NOR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115442 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR