BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1801855 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02542
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE PATIENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT OF EXCESSIVE AIR IN THE LINE (B)(6) 2010. THE PATIENT STATED SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THE PATIENT REPORTED THAT A MONTH AGO SHE TRANSFERRED TO HEMODIALYSIS AND HAD HER CATHETER REMOVED (B)(6) 2010. PATIENT DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE PATIENT DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBER. THE LOT NUMBER WAS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK YOUR POSITION ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING FILL 1. THE HOME PATIENT (HP) REPORTED THERE WAS AIR IN THE PATIENT LINE DUE TO A CLOSED CLAMP. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP WITH ENDING THERAPY. THE HP WILL RESTART WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR DEVICE REPLACEMENT. ADDITIONALLY, A SEPARATE RV PACE/SENSE LEAD WAS IMPLANTED AND SURGICALLY CAPPED FOR FUTURE ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR