BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1912973 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06458
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ROOT CAUSE FOR THE SYSTEM ERROR 2240 (AIR IN SET) WAS DETERMINED TO BE USER ERROR. THE ROOT CAUSE OF THIS COMPLAINT WAS USER ERROR. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH THE (B)(6) THROUGH BAXTER'S AFTERHOURS CALL SERVICE. THE CUSTOMER REPORTED A 2240 ALARM (AIR IN SET) WHILE ON THE HOMECHOICE DEVICE DURING DRAIN. THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE ALARM. THE HOME PATIENT STATED THAT HE DISCONNECTED HIMSELF IN THE DWELL AND WHEN HE CAME BACK, RECONNECTED, AND AS SOON AS HE DID, THE HOMECHOICE MACHINE STARTED ALARMING. THE HOME PATIENT WAS INFORMED THAT HE WOULD NEED TO START OVER WITH NEW SUPPLIES OR FINISH WITH MANUAL SUPPLIES. THE HOME PATIENT STATED THAT HE JUST WANTS TO END THE THERAPY AND THAT HE'LL CONTACT HIS RENAL NURSE WITHIN THE NEXT 24 HOURS. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED. NO SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. THE PT UNDERWENT THE INDEX PROCEDURE WITH PRE-TREATMENT BALLOON ANGIOPLASTY AND DELIVERY OF AN ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT IN THE 2ND OM. ACCORDING TO THE CARDIAC CATHETERIZATION REPORT, A MID VESSEL DISSECTION OCCURRED IN THE LAD AS THE VESSEL WAS WIRED. PRE-DILATION WAS PERFORMED AND THE LAD WAS STENTED WITH THREE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS TO TACK DOWN THE DISSECTION DISTALLY AND TREAT THE LESION PROXIMALLY. THE REESTABLISHMENT OF AT LEAST TIMI 2 FLOW TO THE ARTERY WAS NOTED WITH GOOD RUNOFF DISTALLY. THE ANGIOGRAPHIC CORE LAB REPORTED ON A LESION IN THE 2ND OM WITH A 10% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3. THE CORE LAB FURTHER REPORTED ON A LESION IN THE PROX LAD WITH A 20% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW WITH A NOTATION OF A SPIRAL DISSECTION AFTER PRE-DILATION WHICH WAS TREATED AND COMPLETELY COVERED WITH STENTING. THE PRE-PROCEDURE CARDIAC ENZYMES DRAWN WERE A CK OF 86 (NL 236, RATIO <1) WITH A CKMB OF 0.9 (NL 5, RATIO <1). POST-PROCEDURE THE CK WAS 99 (RATIO <1) WITH A CKMB OF 4.6 (RATIO <1). APPROX 6 HOURS POST INDEX PROCEDURE, THE CK WAS 230 (RATIO <1) WITH AN ELEVATED CKMB OF 25.3 (RATIO 5.1). ONE DAY POST INDEX PROCEDURE, THE CK WAS 255 (RATIO 1.1) WITH A CKMB OF 26.9 (RATIO 5.4). THE TROPONIN LEVELS WERE NOT DONE. THE PRE-PROCEDURE AND POST-PROCEDURE EKG TRACINGS ARE AVAILABLE FOR CEC REVIEW. THE PT WAS DISCHARGED ON ASA AND CLOPIDOGREL ONE DAY POST INDEX PROCEDURE. (REF MFR # 2953200-2010-02647 AND MFR # 2953200-2010-02648).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1