BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2101253 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06431
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 30, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. LABELING REVIEW FINDS THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 AND SE 2367 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL. THE HOME PATIENT (HP) STATED THAT SHE HAD ALARMS THE OTHER DAY AND WAS NOT ABLE TO USE THE HC. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HP TO REVIEW ALARM LOG. FIRST ALARM WAS SE 2367 ON (B)(6) 2011 AND JUST FEW MINUTES PRIOR WAS SE 2240. THE HP STATED THAT SHE WAS CONNECTED AND IN THE BEGINNING OF THE TREATMENT. THE HC WAS STILL SET UP FROM THAT NIGHT. THE RED CLAMP ON THE HEATER BAG WAS OPEN AND THE LINE WAS FULL OF FLUID. THE 2ND BAG WAS ON WHITE CLAMP WHICH WAS ALSO OPEN AND FULL OF FLUID. THE BLUE CLAMP ON 3RD UNUSED LINE WAS OPEN AS WELL. THE TSR EXPLAINED THE ALARM SE 2240 AND SE 2367 AND STATED THAT THE THERAPY WAS OVER AND NEW SUPPLIES WERE TO BE USED. THE HP UNDERSTOOD. THE TSR ALSO TOLD HER SHE SHOULD CONTACT HER REGISTERED NURSE (RN) AND TELL THEM ABOUT THE ALARM. THE HP WILL CALL THE RN AND USE NEW SUPPLIES FOR THAT NIGHT. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER SPOKE WITH THE HOME PATIENT'S (HP) NURSE ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE NURSE SAID THE PATIENT JUST LEFT THE CLINIC AND SHE DID NOT MENTION THE ALARM. THE NURSE SAID HER THERAPY WAS GOING FINE AND SHE HAD NOT HAD ANY PROBLEMS. THE WRITER EXPLAINED THE USE ERROR AND RECOMMENDED RETRAINING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 67 YR