BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1844416 · Received September 25, 2010

    Report

    Report Number
    1423500-2010-03730
    Event Type
    Malfunction
    Date Received
    September 25, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 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). PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) WHO STATED SHE WAS TOLD TO DISCONNECT AND START OVER WITH NEW SUPPLIES WHEN AIR IS SEEN. THE HP STATED THAT NO INJURIES/INFECTIONS HAD OCCURRED SINCE THE ALARM. 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 DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG ELUTING STENTS WERE IMPLANTED IN THE 1ST OBTUSE MARGINAL DURING THE INDEX PROCEDURE (REF MFR# 2953200-2010-02399). IT WAS REPORTED THAT AN MI OCCURRED ONE DAY POST STENT IMPLANT. MI WAS CATEGORIZED AS A NON Q WAVE MI IN THE TERRITORY OF THE TARGET VESSEL. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. NO FURTHER DETAILS ARE AVAILABLE. IT WAS REPORTED THAT 30 DAYS, 6 MONTHS AND 1 YEAR POST THE INDEX PROCEDURE, THE PT WAS FREE OF SYMPTOMS. HOWEVER, AT 1.5 YEARS AND 2 YEARS POST THE INDEX PROCEDURE, THE PT WAS DIAGNOSED WITH STABLE ANGINA.

    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 (HC) UNIT DURING DWELL 2 OF 5. THE HP STATED A SUPPLY BAG FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE POWER TO CLEAR ERROR ALARM. THE TSR THEN INSTRUCTED THE HP TO DISCONNECT USING ASEPTIC TECHNIQUE. THE HP CONFIRMED TO NOTIFY HER NURSE OF THIS INCIDENT. 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