BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1914903 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06566
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 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 WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) DEVICE DURING DRAIN 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND HAD HP CYCLE POWER 2 TIMES TO CLEAR THEM. THE HOMEPATIENT (HP) STATED THAT HE DISCONNECTED HIMSELF TO USE THE RESTROOM AND WHEN HE RETURNED, HC STARTED ALARMING, SO HP CONNECTED BACK TO THE PATIENT LINE. THE TSR EXPLAINED THAT HP WILL NEED TO START OVER WITH NEW SUPPLIES, OR FINISH WITH MANUAL SUPPLIES. HP STATED THAT HE WILL FINISH WITH MANUAL SUPPLIES. TSR ADVISED HP TO CALL RN IN THE NEXT 24 HOURS AND EXPLAIN WHAT HAPPENED. PRODUCT SURVEILLANCE CONTACTED THE PD NURSE ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM AND SHE STATED THAT SHE WAS AWARE OF THE REPORTED ALARM, AND SHE HAS SEEN THE HP SINCE THEN AND STATED THAT EVERYTHING IS FINE. SHE STATED THAT NO INJURY OR MEDICAL INTERVENTION OCCURRED AS A RESULT OF THE HP DISCONNECTED AND RECONNECTED AND STATED THAT THE HP IS RESUMING THE THERAPY ON THE CYCLER.

    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