BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1932669 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07048
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE CONNECTION ISSUE WAS DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SUPPLY BAG FALLING AND DISCONNECTING. GTS ADVISED THE HP TO END THERAPY TO START OVER WITH NEW SUPPLIES OR CONTINUE WITH MANUAL SUPPLIES. ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT HE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP COULD NOT THINK OF ANYTHING THAT MAY HAVE CAUSED THE BAG TO FALL. THE HP WAS RESUMING THERAPY WITHOUT INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE APD CYCLER