BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1813092 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02830
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 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). THIS REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE ROOT CAUSE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE RESULTS OF A LABEL REVIEW REVEALED THAT THERE WAS ADEQUATE LABELING FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING LOW VOLUME DRAIN (NO ALARM) WHICH OCCURRED ON THE HOMECHOICE(HC) DURING USE, DURING INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOMEPATIENT(HP) CHECK THE PATIENT LINE CLAMP AND IT WAS CLOSED. THE TSR HAD THE HP CHECK THE PATIENT LINE AND THE HP STATED THAT THERE WAS AIR IN THE TUBING. THE TSR ASSISTED THE HP WITH ENDING THERAPY AND RESTART WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THE CG STATED THERE WAS A CLAMP OPEN ON AN UNUSED LINE; THE CG CONFIRMED TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE CG WHO STATED THE SET-UP WAS DISCARDED AND THERAPY RESTARTED. THE CG CONFIRMED THE HOME PATIENT HAS BEEN CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 77 YR