BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212382 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10734
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED BASED ON HOME PATIENT (HP) STATING THAT THEY DID NOT USE A VENTED RING CAP ON THE LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A PATIENT THAT NEEDED TO REPRIME THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WALKED THROUGH REPRIME OF THE PATIENT LINE PROCEDURE 4 TIMES AND LINE WOULD NOT PRIME. THE HOME PATIENT (HP) LEFT THE VENTED RING CAP ON THE PATIENT LINE (DID NOT PUT FLEX CAP ON). THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED EVENT. THE HP STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE OR BAGS THAT WERE IN USE. THE HP STATED THEY DISCARDED ALL OF THE SAMPLES AND DID NOT KNOW THE LOT NUMBER OF THE SUPPLIES. THE HP STATED THEY DID NOT USE A VENTED RING CAP ON THE LINE. THE HP STATED THAT THEY WERE ABLE RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 72 YR HOMECHOICE