BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1970654 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01021
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 5, 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE PATIENT STATED THAT THERE IS AIR IN THE PATIENT LINE. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A CHECK PATIENT LINE ALARM WHILE ON THE HOMECHOICE DEVICE DURING INITIAL DRAIN 1. THE HOMEPATIENT (HP) STATED THAT THERE WERE AIR BUBBLES IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED WITH ENDING THERAPY ON THE CYCLER AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(4) 2011 REGARDING THE CHECK PATIENT LINE ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED, HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE HP STATED THAT WHEN SHE CALLED IN THE ALARM WAS WHEN SHE NOTICED THE BUBBLES IN THE PATIENT LINE. THE HP SAID SHE TRIED TO WORK THE BUBBLES OUT BUT THEY WOULD JUST BECOME SMALLER AND SMALLER AND WOULD EXIT THE LINE. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. HP DID NOT REMEMBER IF SHE MENTIONED THE INCIDENT TO HER NURSE AND CONFIRMED SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOMECHOICE