BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX AUTOMATED COAGULATION ANALYZER CA-1500

    MDR report key: 1950887 · Received August 9, 2010

    Report

    Report Number
    1422681-2010-00008
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    April 6, 2010
    Report Date
    June 16, 2010
    Manufacturer
    SYSMEX CORP
    Product Code
    JPA
    PMA / PMN Number
    K011235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR SYSMEX CORP (B)(4) PERFORMED INVESTIGATION AND CORRECTIVE ACTION. ROOT CAUSE INVESTIGATION: OBSERVATION OF DEFECTIVE PARTS REVEALED THAT A CRACK WAS GENERATED AT THE DRIVING PART OF THE SAMPLE TUBE. THE INVESTIGATION CONFIRMED THAT THERE IS NOT ANY PROBLEM IN QUALITY OF THE TUBING MATERIAL AND IN THE MFG PROCESS. HOWEVER, THE DRIVING PART OF THE SAMPLE TUBE MAY CONTACT A BUR AND/ OR ROUGH EDGE GENERATED DURING SPOT WELDING ON THE FRAME. CONSIDERING ITS MOVEMENT, THE CONTACT IS RARE. IN CONCLUSION, THE LIKELY CAUSE FOR THE MICRO-HOLE (CRACK) IN THE SAMPLE ARM TUBING WAS CAUSED BY THE MOVEMENT OF ITS DRIVING PART IN LONG TERM USE, PROBABLY BY CONTACT WITH SOME BURR AND ROUGH EDGE ON THE FRAME. FCA TO BE TAKEN IN THE NEAR FUTURE: THE SAMPLE ARM TUBING WILL BE COVERED BY A "SLEEVE" TO PROTECT IT FROM MECHANICAL VULNERABILITY. AUGUST 2010 THROUGH OCTOBER 2010; ADDITIONAL INFO-PREVIOUS COUNTERMEASURES PERFORMED: RELEASED THE GUIDELINES "PROCEDURE HOW TO EXCHANGE TUBES ON CA-1500" JUNE 2008; EXECUTED DESIGN CHANGE REGARDING THE ROUTING OF THE TUBING IN OUR MFG PROCESS. OCTOBER 2008; SHIPPED 1,000 CA-1500S FOR OVERSEAS AND 70 FOR (B)(4) MARKET AFTER DESIGN CHANGE. NO COMPLAINTS HAVE BEEN RECEIVED REGARDING A MICRO HOLE IN THE CA-1500S AFTER THE DESIGN CHANGE. METHOD: THE INVESTIGATION INTO ROOT CAUSE WAS PERFORMED BY (B)(4). CONCLUSION: FIELD CORRECTION BY (B)(4).

    Description of Event or Problem · 1

    RANDOMLY INCORRECT ELEVATED PT AND APTT RESULTS WERE REPORTED ON (B)(6) 2010, CAUSED BY LEAKAGE FROM THE CA-1500 SAMPLE ARM TUBING IN THE ANALYZER. ONE PT (HOSPITAL IDENTIFIER: PT 1-FEMALE) HAD A POSSIBLE CHANGE TO THEIR DOSAGE OF WARFARIN BASED ON THE ERRONEOUS RESULT. TWO PTS (HOSPITAL IDENTIFIERS: PT 2-MALE AND PT 6-FEMALE) RECEIVED INCORRECT MEDICAL TREATMENT (TRANSFUSION OF BLOOD PRODUCTS) AS A RESULT OF THE INCORRECT REPORTS. NO ADDITIONAL PT IMPACT WAS REPORTED. PT 6-FEMALE: WAS TESTED AT 715 PM ON (B)(6) 2010. THIS PT WAS GIVEN FOUR UNITS OF FRESH FROZEN PLASMA (FFP) AND 4 UNITS OF CRYOPRECIPITATE (CRYO). REPEAT TESTING OF THE SAME SAMPLE GAVE NORMAL RESULTS; THEREFORE THE 8 UNITS OF BLOOD PRODUCT ADMINISTERED WAS UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX AUTOMATED COAGULATION ANALYZER CA-1500 CA-1500 JPA SYSMEX CORP CA-1500 W/CP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other