BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1891921 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05366
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRST OF 4 EMDRS. 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). ONE OF 4 EMDRS. THIS COMPLAINT WAS FOR A DISCONNECTION OF A SUPPLY BAG. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF CASSETTE SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AQUASET 12 BLOOD LINE SET WAS INVOLVED IN AN INCIDENT THAT REFERRED TO A TEAR IN THE BLOOD PUMP SECTION OF THE TUBING. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT THE SET HAD BEEN SET UP ENSURING NO TUBING WAS CAUGHT IN THE DOORS OR AROUND THE PUMP. THERE WERE NO ALARMS; A NURSE NOTICED THE LEAKAGE AND THEN THE TEAR AROUND THE BLOOD PUMP SECTION OF THE TUBING. THERE WERE NO ISSUES WITH THE MACHINE; EVERYTHING HAD BEEN WORKING WELL FOR APPROXIMATELY 24 HOURS UNTIL THE TEAR WAS FOUND. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT FOR ONE (1) UNSPECIFIED RENAL PRODUCT IN WHICH THE LUER CONNECTOR "POPPED APART" 3 OR 4 HOURS INTO THE PATIENT'S THERAPY ON AN UNKNOWN DATE. DURING A FOLLOW-UP WITH THE NURSE, SHE REPORTED THAT THERE WAS NO PERITONITIS OR ANY OTHER ADVERSE EVENTS. THE NURSE STATED THE HP ENDED THERAPY, CLAMPED OFF THE LINES AND ENDED THERAPY WHEN THIS OCCURRED. DURING A FOLLOW UP WITH THE HP REGARDING THE SEPARATION, THE HP REPORTED THAT THE LUER-LOCK CONNECTION BETWEEN THE CASSETTE AND THE HEATER BAG SEPARATED A TOTAL OF FIVE TIMES THUS FAR. THE FIRST TIME IT HAD HAPPENED WAS IN (B)(6) 2010 (SEE EMDR REPORT #1423500-2010-01831). PER HP, ALL THE REST OF THE TIMES THE LUER-LOCK CONNECTIONS SEPARATED BETWEEN THE CASSETTE AND BAG WERE DURING PRIMING AND HP WAS NOT CONNECTED. THE HP DID NOT REMEMBER THE DATES OF ANY OF THE ABOVE EVENTS. THE HP STATED THAT SHE HAD NOT NOTICED ANY DEFECTS ON THE SUPPLIES DURING SETUP. THE HP STATED THAT THE SEPARATIONS OCCURRED ON ITS OWN AND SHE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE SEPARATIONS. THE HP CONFIRMED THAT SHE HAS ALREADY DISCUSSED THE ISSUES WITH THE NURSE. THE HP CONFIRMED THAT SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THESE INCIDENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 63 YR