BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1893913 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05504
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 SUPPLIES WERE DISCARDED THEREFORE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 4/5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING SYSTEM ERROR 2240 ALARM WHICH OCCURRED ON THE HOME CHOICE (HC) DURING USE, DURING DWELL 4 OF 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ITS POSSIBLE CAUSES. THE TSR ADVISED THE CG TO CLOSE THE CLAMPS AND CYCLE THE POWER TO CLEAR BOTH THE SYSTEM ERROR 2240 ALARM AND THE SYSTEM ERROR 2367 ALARM. THE TSR THEN ADVISED THE CG TO DISCARD THE SUPPLIES AND TO FINISH WITH NEW MANUAL SUPPLIES. THE SOLUTION TO THE PROBLEM WAS PROVIDED OVER THE PHONE. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S (HP) NURSE WHO STATED THAT SHE WAS AWARE OF THE ALARMS BECAUSE THE HP'S HUSBAND CALLED HER. THE NURSE CONFIRMED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE NURSE STATED THAT SHE THINKS THE ALARMS MAY BE DUE TO THE HP USING BAGS THAT ARE NOT MADE BY BAXTER. THE NURSE STATED THAT THE HP REQUIRES A PROTEIN THAT IS PUT INTO SALINE INSTEAD OF THE DEXTROSE BAGS BAXTER MAKES. NO FURTHER INFORMATION WAS PROVIDED.

    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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR