BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930925 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06982
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 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. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A CONNECTION ISSUE - DISCONNECTION OF A SUPPLY BAG. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB 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 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 CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH GETTING THE CASSETTE OUT ON THE HC ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 4. THE HOME PATIENT (HP) WAS CONNECTED TO THE HC MACHINE WHEN THE BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY PER THEIR REQUEST. THE HP WILL CONTACT THE NURSE REGARDING THE DISCONNECTION AND ANY MISSED THERAPY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT THE ISSUE WAS WITH THE MACHINE. WHEN ASKED TO ELABORATE, THE HP SEEMED A BIT CONFUSED. WHEN ASKED IF THERE WAS ANYTHING WRONG WITH THE CASSETTE OR BAG THAT CAUSED THE SEPARATION THE HP STATED 'NO'. WHEN ASKED IF THEY HAD KNOCKED THE SUPPLIES OFF OF A TABLE, THE HP STATED 'NO'. THE HP NOTIFIED HIS NURSE AND SAID THEY WERE GIVEN ANTIBIOTICS. WHEN ASKED IF THE SUPPLIES WERE DISCARDED, THE HP STATED 'YES' AND WHEN ASKED IF THEY KNEW ANY LOT NUMBERS OR PRODUCT CODES, THE HP STATED 'NO'. THE HP HAS CONTINUED THERAPY.

    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 65 YR PD CYCLER