BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1871912 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04510
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 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). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS PATIENTS HOW TO DISCONNECT DURING AN EMERGENCY FOR A SHORT TIME. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS NOT AVAILABLE. 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 1. THE CAREGIVER (CG) STATED THAT THE PATIENT DISCONNECTED TO USE THE RESTROOM, AND THEN RECONNECTED. THE PATIENT WAS ADVISED TO DISCARD THE SUPPLIES AND START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT HAS RESUMED THERAPY SUCCESSFULLY SINCE THIS EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD AN INCREASE IN RIGHT ATRIAL (RA) PACING THRESHOLDS MEASUREMENTS. FLUOROSCOPY INDICATED THE RA LEAD HAD PULLED BACK. THE LEAD ATTEMPTED TO BE EXTRACTED, BUT WAS FIBROSED TO THE DISTAL COIL OF THE PATIENT'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THE RV LEAD HAD PULLED BACK AND WAS PARTIALLY IN THE TRICUSPID VALVE. THE RA AND RV LEAD WERE SUCCESSFULLY EXTRACTED. A NEW RV LEAD WAS SUCCESSFULLY PLACED. THE RA LEAD WAS IMPLANTED AND DURING TESTING, IT WAS NOTICED THAT THE RV LEAD HAD AN ADDITIONAL AMOUNT OF SLACK IN IT. FLUOROSCOPY WAS TURNED ON AND THE RV LEAD JUMPED FORWARD AND WAS AT THE EDGE OF THE CARDIAC SILHOUETTE. THERE WAS SPECULATION THAT THE LEAD MAY HAVE PERFORATED. IT WAS REPORTED THAT SIMULTANEOUSLY THE PATIENT'S BLOOD PRESSURE INCREASED AND THE EKG RHYTHM CHANGED. THE HELIX WAS RETRACTED AND THE LEAD WAS REPOSITIONED. THE PATIENT WENT INTO CARDIAC TAMPONADE AND A CODE WAS CALLED. THE PATIENT SUBSEQUENTLY HAD AN IMPELLA PUMP AND A BALLOON PUMP IMPLANTED. ONE DAY LATER, TACHYCARDIA THERAPY WAS TURNED OFF AND THE PHYSICIAN ORDERED A DO NOT RESUSCITATE (DNR). THE PATIENT LATER DIED AND BRADY THERAPY WAS TURNED OFF POST- MORTEM. THE DEVICE PLANNED TO BE BURIED WITH THE PATIENT.

    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 35 YR