BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1834016 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03400
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 23, 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 SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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).

    Description of Event or Problem · 1

    IN RESPONSE TO (B)(6) HOSPITAL'S (B)(6) RECEIVED ON AUGUST 9TH, 2010. (B)(6) RE-IN SERVICED THE OPERATING ROOM NURSING STAFF ON (B)(6) 2010 ON HOW TO PROPERLY OPERATE THE EMERGENCY BRAKE RELEASE. THE OPERATING ROOM STAFF AGREED THAT THE TABLE DID NOT FAIL. ONE OF THE STAFF, BY MISTAKE, OPENED UP THE EMERGENCY BRAKE RELEASE VALVE. DURING THE OPERATING ROOM PROCEDURE, NO ONE REALIZED THAT THE BRAKE SYSTEM HAD BEEN OPENED. THERE WAS A PT ON THE TABLE WHEN THIS HAPPENED AND WAS NOT INJURED OR COMPROMISED. (B)(6) REP RE-IN SERVICED ALL THE SHIFTS IN LABOR AND DELIVERY ON (B)(6) 2010 AND MADE SURE THAT ALL NURSING STAFF WERE PROPERLY EDUCATED WITH OUR 6701 TABLE, AND THE ACCESSORIES ASSOCIATED WITH THE TABLE.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE UNIT DURING DWELL 3 OF 5. THE TSR EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP STATED THAT SHE ONLY HAD ONE BAG OF FLUID LEFT SO SHE ONLY HAD HER LAST CYCLE. THE HP STATED SHE WOULD CALL THE PERITONEAL DIALYSIS NURSE IN THE MORNING AND DO A MANUAL EXCHANGE WHEN SHE WAKES UP. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR