BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1790178 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02313
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 18, 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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER AND REPORTED A SUPPLY BAG FELL DURING FILL 1. THE HOME PATIENT (HP) STATED THE SUPPLY BAG FELL AND DISCONNECTED. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE REPORTED INCIDENT. THE HP STATED THE CAUSE OF THE SUPPLY BAG FALLING WAS DUE TO HIS FOOT GETTING CAUGHT IN THE LINE WHEN HE GOT UP TO USE THE RESTROOM. THE SET-UP WAS DISCARDED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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