BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1914882 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06550
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 12, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE PRODUCT USED IS UNKNOWN AND THEREFORE THE 510(K) NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.(B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED EPISODES OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, RESULTING IN INAPPROPRIATE SHOCK AND EPISODES OF ASYSTOLE. THIS PRODUCT HAD RECENTLY BEEN IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS PACER DEPENDANT AND EXPERIENCED DIZZINESS WITH THE EPISODES OF ASYSTOLE. DUE TO THE NOISE RECORDED ON THE RV CHANNEL THE PHYSICIAN ELECTED TO REPLACE THE PATIENT'S CHRONIC RV LEAD AND SINCE THEN NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE ROOT CAUSE OF THE NOISE IS UNKNOWN AT THIS TIME AS THE RV LEAD WAS SURGICALLY CAPPED, WE ARE UNABLE TO RULE OUT DEVICE INVOLVEMENT IN THE CLINICAL OBSERVATIONS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THIS IS REPORT NUMBER 2 OF 5 RECEIVED BY BAXTER (B)(4) FROM A PHYSICIAN FOR AN INCREASE IN PERITONITIS CASES AT THIS FACILITY. THE PATIENT'S DOCTOR REQUESTED AN INVESTIGATION SINCE THE NUMBER OF PERITONITIS EVENTS WAS INCREASED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR (B)(6) ON (B)(6) 2010 AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. THE PATIENT WAS TREATED WITH TRIFLUCAN 100 MILLIGRAMS INTRAVENOUSLY. THE PATIENT CONTINUED THERAPY USING HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DEVICE (B)(4) HOMECHOICE AUTOMATED PERITONEAL DIAL