BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1760876 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01537
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 3, 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). NO SAMPLE WAS AVAILABLE: THE DEVICE WAS DISCARDED AND NO COMPANION SAMPLE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED AND A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO THE PATIENT PLACING THE SOLUTION BAG ON AN UNSTABLE SURFACE AND THE SOLUTION BAG DISCONNECTED DURING THERAPY. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 AN ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 2 OF 4. THE HOME PATIENT (HP) STATED ONE OF THE BAGS FELL AND THE SPIKE CAME OUT. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010. THE HP STATED THAT HE WAS ON VACATION SO THE ARRANGEMENT WAS DIFFERENT. THE HP HAD GOTTEN HIS FOOT CAUGHT IN THE LINE, RESULTING IN THE BAG FALLING AND DISCONNECTING. (THE HP DID KNOW THE PROPER PROCEDURE AND IT WAS AN ISOLATED INCIDENT.) PER THE RN'S INSTRUCTION, THE HP SHUT OFF THE MACHINE FOR THE NIGHT AND DID A MANUAL EXCHANGE THE NEXT MORNING AND AFTERNOON. THE HP HAS BEEN DOING FINE AND CONTINUING THERAPY ON THE CYCLER AS USUAL.

    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 56 YR