BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON UNIVERSAL PUMP

    MDR report key: 7568231 · Received June 5, 2018

    Report

    Report Number
    3005619970-2018-00008
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS TO INFORM YOU ON THE PROGRESS MADE SO FAR. THE DEVICE WAS NOT EVALUATED BY ARJO TECHNICIAN, BUT THE CUSTOMER IS COMPILING THEIR FINAL REPORT AS PART OF THEIR INVESTIGATION. WE HAVE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER AND OBTAIN FURTHER INFORMATION REGARDING THE INCIDENT AND ACCESS THEIR FINAL REPORT. THUS FAR WITHOUT SUCCESS. LAST ATTEMPT WAS MADE ON 10TH JULY 2018. CURRENTLY WE ARE WAITING FOR THE CUSTOMER'S FEEDBACK. AS SOON AS INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN CARRIED OUT INTO THIS COMPLAINT AND THE RESULTS ARE FOLLOWING. THE NURSE ALLEGED THAT SHE RECEIVED AN ELECTRIC SHOCK WHEN PLUGGING IN THE MAIN POWER INTO THE POWER SOCKET. THE PUMP WAS NOT RELEASED FOR ARJO EVALUATION, BUT THE CUSTOMER HAS PERFORMED THEIR INTERNAL PUMP EVALUATION. AFTER MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER AND RECEIVE REPORT FROM THE INVESTIGATION, THE FINAL REPORT ON THE REPORTED INCIDENT WAS PROVIDED TO ARJO ON 31 AUG 2018. ACCORDING TO THE REPORT, THE NURSE STATED THAT "SHE SAW AS A FLAME PASS OVER THE INDEX FINGER OF HER GLOVE AND THEN IT EXTINGUISHED". THE NURSE DID NOT FEEL IMMEDIATE PAIN OR SENSATION. SHE LATER NOTICED SOME REDNESS ON HER INDEX FINGER. THE NURSE WAS WEARING A RUBBER GLOVE AT THE TIME OF THE INCIDENT. VISUAL INSPECTION REVEALED THAT THE PLUG FROM MAIN CABLE HAD MISSING EARTH PIN. NO OTHER DAMAGES OR BURN WAS DETECTED. THE PLUG PLASTIC MOLDING WAS INTACT. FURTHERMORE, IT WAS CONFIRMED WITH THE FLOWTRON UNIVERSAL MANUFACTURER THAT THE PUMP IS DOUBLE INSULATION PROTECTION WITH FUNCTIONAL EARTH. EVEN IF THERE WAS A PIN MISSING, THIS WILL NOT CAUSE AN ELECTRIC SHOCK. THE CUSTOMER'S EVALUATION CONFIRMED THAT THERE WAS NO ELECTRICAL SHOCK BUT RATHER A FRIGHT. THE CUSTOMER SUGGESTED IN THEIR REPORT THAT THE CAUSE OF THE INCIDENT WAS PUSHING THE PLUG INTO THE SOCKET WHILE THE PUMP WAS ON AND THE POWER SOCKET WAS LIVE, WHICH COULD CAUSE SPARK AND ELECTRICAL CIRCUIT BREAKER TO TRIP. ACCORDING TO THE REPORT THERE WAS POSSIBILITY, "THAT IF THERE WAS SUFFICIENT MOISTURE ON THE VICTIM'S' RUBBER GLOVE, THE CURRENT COULD HAVE PASSED OVER THE SURFACE OF THE GLOVE AND ARCED TO THE EARTHED PANEL OF THE PENDANT. THE RUBBER GLOVE WOULD ISOLATE VICTIM FROM THE ELECTRICAL CURRENT." THE OTHER REASON FOR THE SPARK COULD HAVE BEEN RELATED TO THE SOCKET ON THE WALL ITSELF. NONE OF THE ABOVE SUGGESTED SCENARIOS COULD HAVE BEEN CONFIRMED. FLOWTRON UNIVERSAL INSTRUCTION FOR USE STATES THAT "IT IS THE RESPONSIBILITY OF THE CARE GIVER TO ENSURE THAT THE USER CAN USE THIS PRODUCT SAFELY". THE SYSTEM HAS BEEN DESIGNED TO COMPLY WITH REGULATORY SAFETY STANDARDS INCLUDING: EN60601-1:1990/A13:1996 AND IEC 60601-1:1988/A2:1995. UL60601-1, UL2601-1 AND CAN/CSA C22.2 NO. 601.1-M90. FROM THE ABOVE IT CAN BE CONFIRMED THAT MISSING EARTH PIN IN MAIN CABLE PLUG WILL NOT RESULT IN ANY ELECTRIC SHOCK. THE NURSES ALLEGATION COULD NOT HAVE BEEN CONFIRMED. IN SUMMARY, THE DEVICE WAS USED FOR A PATIENT HANDLING AT THE TIME OF THE INCIDENT AND IN THAT WAY PLAYED A ROLE IN THE EVENT. IT FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE PLUG HAD MISSING EARTH PIN. THIS HOWEVER WILL NOT RESULT IN AN ELECTRIC SHOCK. COMPLAINTS WERE MISSING EARTH PIN IS MENTIONED ARE NOT CONSIDERED SAFETY RELATED.

    Additional Manufacturer Narrative · 0

    ARJO HAS NOT YET RECEIVED A FINAL REPORT FROM THE CUSTOMER. CUSTOMER IS STILL IN THE PROCESS OF EVALUATING THE EVENT. AS SOON AS FINAL CONCLUSION FROM CUSTOMER'S EVALUATION WILL BE AVAILABLE TO ARJO, FINAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE NURSE WAS PLUGGING IN THE UNIT INTO THE MAINS WALL SOCKET A SHORT CIRCUIT OCCURRED, WHICH CREATED AN ELECTRIC SHOCK. EARTH PIN WAS MISSING. INITIAL INSPECTION OF THE PLUG AND CABLE REVEALS THAT THE CABLE AND CABLE GRIP MOULDINGS WERE INTACT ON THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412976 FLOWTRON UNIVERSAL PUMP SLEEVE, LIMB, COMPRESSIBLE JOW GETINGE (SUZHOU) CO., LTD. 507009AU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other