BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2884098 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07977
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 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). EVALUATION SUMMARY: THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE PROBLEM WAS CONFIRMED, AS IT WAS REPORTED THAT THE CASSETTE WAS NOT CONNECTED TO THE BAGS PROPERLY. THEREFORE THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR. ADDITIONAL INFORMATION: THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. THIS CONDITION OF A CONNECTION ISSUE WAS CONFIRMED, AS IT WAS REPORTED THAT THE CUSTOMER DID NOT CONNECT THE CASSETTE LINES TO THE BAGS PROPERLY. ADDITIONAL INFORMATION: A REVIEW OF THE PRODUCT LABELING WAS PERFORMED AND FOUND THE LABELING TO BE ADEQUATE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER STATING THAT THE BAGS WERE NOT CONNECTING WITH THE ADAPTORS AND THE CASSETTE LINES, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE CG STATED THAT THEY RECEIVED NEW BOXES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF THE CASSETTES HAD AN L5C NUMBER AND THE CG STATED YES. THE TSR ASKED IF THE BAGS HAD AN L5B NUMBER AND THE CG STATED THAT THE BAG HAD AN L5B9771 NUMBER. THE TSR EXPLAINED THE LINE WITH THE RED CLAMP SHOULD CONNECT TO THE BAG WITHOUT AN ADAPTOR. THE CG STATED THAT THEY WOULD TRY CONNECTING AGAIN AND HUNG UP THE PHONE. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. 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'S CAREGIVER ON (B)(6) 2012 AND SHE SAID THAT SHE WAS ABLE TO RESOLVE THE ISSUE. SHE SAID SHE DID NOT CONNECT THE CASSETTE LINES TO THE BAGS PROPERLY, BUT AFTER TALKING WITH THE TSR SHE WAS ABLE TO CONNECT THE LINES AND BAGS CORRECTLY. SINCE THEN THE PATIENT HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    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 74 YR HOME CHOICE