BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-1500 ANALYZER

    MDR report key: 3935842 · Received June 27, 2014

    Report

    Report Number
    3009711478-2014-00016
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX CA-1500 AUTOMATED BLOOD COAGULATION ANALYZER WITH CAP PIERCER WAS NOT THE DIRECT CAUSE OF, BUT WAS INVOLVED IN, THE REPORTED EVENT. THE USER IS WARNED IN THE SYSMEX CA-1500 SYSTEM OPERATOR'S MANUAL INTRODUCTION PRECAUTIONS TO BE OBSERVED IN SAFE HANDLING OF THE UNIT. THE FOLLOWING IS INCLUDED: WARNING! HANDLE THE PIERCER WITH CARE. THE TOP OF THE PIERCER IS SHARP. IF IT TOUCHES YOUR HANDS OR FINGERS, YOU MAY BE INJURED OR BE INFECTED. BE CAREFUL, SPECIFICALLY WHEN REPLACING". THE CSE, WHO IS FAMILIAR WITH THE INSTRUMENT'S PARTS AND CONFIGURATION, REACHED INSIDE OF THE CAP PIERCER ASSEMBLY TO CHANGE THE PART. THIS AREA MAY BE ACCESSED BY A USER. THE PIERCER IS A CONSUMABLE PART REQUIRED TO BE REPLACED AT LEAST EVERY 30,000 CYCLES OR WHEN THE PIERCER BECOMES WORN OR BENT. DIRECTIONS FOR ITS REPLACEMENT ARE DETAILED IN CHAPTER 7 - MAINTENANCE AND SUPPLIES REPLACEMENT, SECTION 7.7. REPLACING THE PIERCER WARNINGS ARE INCLUDED: "WARNING! THE TIP OF THE PIERCER IS SHARPLY POINTED AND EXTREMELY DANGEROUS. WHEN REPLACING THE PIERCER, WEAR LATEX OR NON-LATEX EXAMINATION GLOVES AND DO NOT TOUCH THE PIERCER TIP. AFTER OPERATION IS COMPLETED, WASH YOUR HANDS WITH DISINFECTANT". THE PERSON PERFORMING THIS PROCEDURE IS ADVISED TO HOLD THE PIERCER BASE THAT IS HELD BY THE FASTENING SCREW AND REMOVE THE FIXTURE THAT FIXES THE PIERCER. THE PERSON IS INSTRUCTED NOT TO TOUCH THE BOTTOM OF THE PIERCER GUIDE. THE SURFACE THAT IMPALED THE ENGINEER'S THUMB WAS SHARP, AND THE THUMB'S LOCATION TO REMOVE THE CAP PIERCER WAS SUCH THAT THE SKIN WAS PENETRATED. NO EVIDENCE WAS PROVIDED TO SUGGEST THAT THE ANALYZER WAS IN OPERATION, A PART WAS NOT INSTALLED CORRECTLY OR THAT THE DEVICE FAILED IN ANY WAY.

    Description of Event or Problem · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPORTED THAT HE WAS INJURED WHILE PERFORMING PREVENTIVE MAINTENANCE ACTIVITIES ON A CA-1500CP AUTOMATED BLOOD COAGULATION ANALYZER WITH CAP PIERCER (SERIAL NUMBER (B)(4)). HE WAS CHANGING THE CAP PIERCER ON THE ANALYZER AND HIS THUMB WAS PENETRATED BY THE SHARP PIERCER. THE CSE WAS WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT, WHICH WAS APPROXIMATELY 3PM. THE INCIDENT WAS REPORTED AS AN EXPOSURE TO ENVIRONMENTAL HEALTH AND SAFETY ()EHS) THROUGH SIEMENS. THE CSE WAS TREATED AT THE EMERGENCY ROOM OF THE CLIENT'S SITE, RECEIVING PROPHYLACTIC ANTI-VIRAL MEDICATION THAT IS CONSISTENT WITH THE CENTERS FOR DISEASE CONTROL'S (CDC) VIRUS-PREVENTION GUIDELINES. THE CSES STATUS IS MONITORED AND WILL CONTINUE TO BE SIX MONTHS POST-EXPOSURE ((B)(6) 2014). RESULTS OF SIX-WEEK TESTING WERE NEGATIVE. SIEMENS REPORTS THAT THE CSE'S CONDITION IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378235 SYSMEX CA-1500 ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-150

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other