BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2873049 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07319
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. BECAUSE OF THE LACK OF A SAMPLE AND LOT NUMBER, THE REPORTED PROBLEM COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. BECAUSE OF THE LACK OF A SAMPLE AND LOT NUMBER, THE REPORTED PROBLEM COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM (LDV), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THEY HAD A WHITE LINE IN THE PATIENT LINE. THE HP STATED IT HAD HAPPENED BEFORE WITH THE REGISTERED NURSE (RN) PRESENT BUT THE RN SAID TO CONTINUE WITH THERAPY AND THAT IT WAS NOT A PROBLEM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO LET THE RN KNOW ABOUT WHITE LINE IN THE PATIENT LINE. THE TSR ADVISED THE HP TO CONTINUE WITH THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(6) 2012 AND THE RN STATED THAT THEY WERE UNAWARE OF THE "WHITE LINE IN THE PATIENT LINE," THE HP HAD NO HISTORY OF FIBRIN, AND THE RN DID NOT BELIEVE IT WAS FIBRIN. THE RN STATED THAT THEY DID NOT KNOW WHAT THE PATIENT WAS REFERRING TO. THE RN STATED THAT AS FAR AS THEY KNEW, THE HP IS COMPLETING THERAPY ON THE HC SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE