BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1888578 · Received November 2, 2010

    Report

    Report Number
    1423500-2010-05210
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. PER CAREGIVER (CG), THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP), ASSISTED TO CLEAR THE ALARM AND ADVISED THE HP TO START OVER AGAIN USING NEW SUPPLIES. DURING A FOLLOW UP WITH THE CG REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED; HOWEVER, SHE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM FOR SURE. PER CG, THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE CG VERIFIED THAT THE HP DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. PER CG, THE HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED STENT FRACTION AND 14% OCCLUSION OF TWO CYPHER STENTS. THIS COMPLAINT IS FROM THE AMERICAN HEART JOURNAL (2010; 160:775.E1-775.E9) ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION". THIS CASE IS 22ND OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN IN-STENT RESTENOSIS, BUT IT WAS A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX STENTS (SIZE AND LOT NUMBER UNKNOWN) WERE IMPLANTED. THE TOTAL STENTED LENGTH WAS 47MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6 TO 9 MONTHS AFTER THE IMPLANT.

    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 79 YR