BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1934834 · Received December 21, 2010

    Report

    Report Number
    1423500-2010-07126
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    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). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS USE ERROR. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING AN ALARM ON THE HOME CHOICE (HC) DURING FILL 4 OF 4. WHILE TROUBLESHOOTING, THE HOME PATIENT (HP) WAS SHAKING THE LAST FILL BAG AND IT BECAME DISCONNECTED. (B)(4) ASSISTED TO END THERAPY AND ADVISED THE HP TO LET THE REGISTERED NURSE (RN) KNOW THE HP DID NOT FINISH THERAPY. BAXTER (B)(4) SPOKE WITH THE CAREGIVER (CG) ON (B)(6) 2010, WHO SAID ALL THE SUPPLIES LOOKED NORMAL. THE CG STATED THAT SHE WAS SHAKING THE BAG AND THE LINES AS PART OF TROUBLESHOOTING TO RESOLVE THE ALARM, AND THAT SHE ACCIDENTALLY SHOOK THE BAG TOO HARD. SHE SAID IT WAS THE LAST FILL BAG, WHICH IS A "PURPLE" BAG. THE CG STATED THAT WHILE SHE WAS SHAKING, THE SPIKE CAME RIGHT OUT OF THE BAG AND FELL ONTO THE CARPET. SHE KNEW THAT WAS BAD, SO SHE CALLED. SHE ALSO CALLED HER NURSE AND AT HER ADVICE THEY CONTINUED THERAPY THAT NIGHT WITH MANUALS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE APD CYCLER