BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3071457 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10019
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING ENDING THERAPY, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT THE KNOB ON THE TRANSFER SET WAS BROKEN. THE HP WAS GOING TO THE CENTER THE FOLLOWING DAY FOR A NEW TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED AS REQUESTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) IN ORDER TO CLARIFY WHAT PART WAS BROKEN ON THE TRANSFER SET SINCE THE TRANSFER SET DOES NOT HAVE A KNOB. THE HP WAS NOT AVAILABLE AT THE TIME OF THE CALL. HOWEVER, THE HP'S WIFE ANSWERED THE PHONE AND WAS ABLE TO ANSWER THE QUESTIONS. THE HP'S WIFE STATED THAT WHEN THE HP CONNECTED THE TRANSFER SET TO THE PATIENT LINE AND THEN WANTED TO OPEN THE TRANSFER SET TO ALLOW THE LIQUID TO MOVE, THE BLUE PART THAT TWISTS OPEN BROKE. THE HP'S WIFE STATED THAT THEY HAD TO END THE THERAPY THAT NIGHT. THE NEXT DAY, THE HP WAS ABLE TO DO A MANUAL DRAIN AND THEN USE A NEW TRANSFER SET WITHOUT HAVING ANY OTHER ISSUES. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172526 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE