BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1834043 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03402
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HP REFUSES TO SEND BACK SAMPLE; HE STATED THAT HIS ATTORNEY WILL LOOK INTO THIS MATTER. PRODUCT SURVEILLANCE ADVISED THE HP THAT IF HE DECIDED TO SEND IN THE SAMPLE, A SAMPLE RETURN KIT SHALL BE PROVIDED SO THAT FURTHER EVALUATION COULD BE PERFORMED ON THE FOREIGN OBJECT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THERE WAS NOT ENOUGH DATA TO IDENTIFY ROOT CAUSE. 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 CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 2 OF 4. THE CAREGIVER STATED THAT THE BAGS WERE ALL STILL CONNECTED AND THAT ONE OF THE BAGS HAD LEAKED OUT ON THE TABLE. THE CAREGIVER STATED SHE WAS UNABLE TO DETERMINE WHERE THE FLUID CAME FROM. THE CAREGIVER HAD ALREADY DISCONNECTED THE BAGS FROM THE SETUP AND CYCLED POWER TO CLEAR THE ERROR. GTS ASSISTED THE CAREGIVER WITH REMOVING THE CASSETTE. THE CAREGIVER ELECTED TO START THE PATIENT'S THERAPY OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    GLOBAL FIELD SURVEILLANCE RECEIVED A REPORT FROM A HOME PATIENT (HP) WHO STATED THAT PRIOR TO CONNECTING THE PATIENT LINE TO HIS TRANSFER SET FOR THERAPY, HE NOTICED A CHUNK OF A BLACK PLASTIC FOREIGN OBJECT 1/16 INCHES WIDE AND 7/16 INCHES LONG LOCATED IN THE PATIENT LINE. THE HP STATED THAT HIS PHYSICIAN AND PERITONEAL DIALYSIS NURSE ARE AWARE OF THE REPORTED FOREIGN OBJECT. THE HP STATED THAT THE ISSUE WAS NOTED WITH ONLY ONE CASSETTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 H10E20062

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR