BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA 1500 WITH CAP PIERCER

    MDR report key: 879342 · Received July 9, 2007

    Report

    Report Number
    1422681-2007-00002
    Event Type
    Other
    Date Received
    July 9, 2007
    Date of Event
    May 15, 2007
    Report Date
    May 25, 2007
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K992423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT ORIGINATED OUTSIDE THE U.S. AND THEREFORE REQUIRED REVIEW BY BOTH FOREIGN DIVISIONS OF SYSMEX CORPORATION PRIOR TO U.S. NOTIFICATION. THE TECHNOLOGIST'S INJURY DID NOT RESULT FROM A FAILURE OF THE SYSMEX CA-1500 TO OPERATE CORRECTLY, A FAILURE OF THE DEVICE TO MEET SPECIFICATIONS NOR WAS IT THE RESULT OF A DESIGN DEFECT OR FAILURE OF A SAFETY FEATURE OR SAFETY COMPONENT OF THE DEVICE. FROM THE AVAILABLE INFORMATION, THE TECHNOLOGIST'S INJURY APPEARS TO HAVE OCCURRED ACCIDENTALLY WHILE PERFORMING ROUTINE ANALYZER MAINTENANCE AS DESCRIBED IN THE CA-1500 OPERATOR'S MANUAL. BASED ON OUR ASSESSMENT, THE ANALYZER OPERATOR'S INJURIES DO NOT QUALIFY AS "SERIOUS"., AS THEY DID NOT APPEAR TO BE LIFE-THREATENING, DID NOT RESULT IN PERMANENT IMPAIRMENT OR DAMAGE TO BODY FUNCTION OR STRUCTURE, AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. SYSMEX REPORTS THIS INJURY FOLLOWING FDA'S NOVEMBER 12, 2002 GUIDANCE DOCUMENT: NEEDLESTICKS: MEDICAL DEVICE REPORTING GUIDANCE FOR USER FACILITIES, MANUFACTURERS AND IMPORTERS, WHERE ADMINISTRATION OF ANTI-RETROVIRAL DRUGS AND PRESCRIPTION MEDICATION WOULD BE CLASSIFIED AS "MEDICAL INTERVENTION" AND REQUIRE AN MDR REPORT.

    Description of Event or Problem · 1

    WHILE CLEANING THE SAMPLE PROBE (PIERCER NEEDLE) OF A CA-1500 AUTOMATED COAGULATION ANALYZER AS PART OF ROUTINE WEEKLY INSTRUMENT MAINTENANCE, A TECHNOLOGIST EXPERIENCED A NEEDLE STICK. THE INSTRUMENT POWER WAS OFF DURING THE MAINTENANCE, BUT THE TECHNOLOGIST COULD NOT VERIFY WHETHER THE AUTOMATED MAINTENANCE SEQUENCE PRIOR TO POWERING OFF THE ANALYZER HAD BEEN COMPLETED. THE TECHNOLOGIST IMMEDIATELY CONTACTED A PHYSICIAN, AND BEGAN TREATMENT WITH ANTI-RETROVIRAL DRUGS. TWO HRS LATER, THE TECHNOLOGIST CONTACTED AN OUTPATIENT CENTER, BECAUSE SHE WAS FEELING NAUSEOUS. AS A RESULT, SHE WAS PUT ON A ONE MONTH REGIMEN OF THE ANTI-NAUSEA/ ANTI VOMITING DRUG, PREIMPERAN, FROM SANOFI AVENTIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX CA 1500 WITH CAP PIERCER AUTOMATED COAGULATION ANALYZER JPA SYSMEX CORPORATION CA-1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention NOT PROVIDED