BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX AUTOMATED COAGULATION ANALYZER CA-1500

    MDR report key: 1950916 · Received August 9, 2010

    Report

    Report Number
    1422681-2010-00007
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    May 6, 2010
    Report Date
    June 16, 2010
    Manufacturer
    SYSMEX CORPORATION
    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. (B)(6), 2010 THROUGH (B)(6), 2010; ADDITIONAL INFO-PREVIOUS COUNTERMEASURES PERFORMED: RELEASED THE GUIDELINES "PROCEDURE HOW TO EXCHANGE TUBES ON (B)(4)" (B)(6), 2008; EXECUTED DESIGN CHANGE REGARDING THE ROUTING OF THE TUBING IN OUR MFG PROCESS. (B)(6), 2008; SHIPPED 1,000 (B)(4)S FOR OVERSEAS AND 70 FOR (B)(6) MARKET AFTER DESIGN CHANGE. NO COMPLAINTS HAVE BEEN RECEIVED REGARDING A MICRO HOLE IN THE (B)(4) AFTER THE DESIGN CHANGE. METHOD: THE INVESTIGATION INTO ROOT CAUSE WAS PERFORMED BY (B)(4) AFFILIATE ((B)(4)). CONCLUSION: FIELD CORRECTION BY SCJ.

    Description of Event or Problem · 1

    RANDOMLY INCORRECT ELEVATED PT AND APTT RESULTS WERE REPORTED ON (B)(6), 2010, CAUSED BY LEAKAGE FROM THE (B)(4) 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 2-MALE: MALE IP GI BLEED- WAS TESTED AT 9 AM ON (B)(6), 2010. AS PT HAD PREVIOUS ABNORMAL RESULTS AND HAD BEEN GIVEN FRESH FROZEN PLASMA (FFP) AND CRYOPRECIPITATE (CRYO), A FURTHER THREE UNITS OF CRYO WAS GIVEN. REPEAT TESTING OF THE SAMPLE GAVE NORMAL RESULTS; THEREFORE, THE THREE UNITS OF CRYO SHOULD NOT HAVE BEEN ADMINISTERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other