BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP6000

    MDR report key: 6013477 · Received October 10, 2016

    Report

    Report Number
    9616031-2016-00005
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 22, 2016
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    FLH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON THIS COMPLAINT. GETINGE RECEIVED A COMPLAINT WHERE IT WAS INDICATED THAT THE PATIENT RECEIVED CHEMICAL BURN ON HER POSTERIOR AFTER USING A BOWL PROCESSED IN WASHER DISINFECTOR MANUFACTURED BY THE GETINGE. THE PRODUCT INVOLVED IN THE INCIDENT IS GETINGE SP-6000 WASHER-DISINFECTOR. AFTER COMPLAINT REVIEW FOR THIS DEVICE WE ARE ABLE TO ESTABLISH THAT THIS ISSUE (CHEMICAL BURN FOR USER/PATIENT) CAN BE CONSIDERED TO BE A SINGLE, ISOLATED EVENT. (B)(4). PRIOR THE INCIDENT OCCURRED THE DEVICE WAS USED FOR DISINFECTING GOODS. AFTER THE PROCESS, THE GOODS WERE TAKEN OUT FROM THE WASHER AND USED BY THE PATIENT. THE MOST PROBABLE ROOT CAUSE OF THE CHEMICAL BURN OF THE PATIENT IS THE CUSTOMER (HOSPITAL) USING A WRONG DETERGENT. THE MATERIAL SAFETY DATA SHEET OF THE MENTIONED IN THE COMPLAINT DESCRIPTION GETINGE DETERGENT DOES NOT CONTAIN ANY POSSIBLY DANGEROUS INGREDIENTS. MOREOVER LOOKING AT THE DILUTION OF THE DETERGENT AFTER THE PROCESS IT IS CONSIDERED AS NOT POSSIBLE THAT OUR DETERGENT PLAYED A ROLE IN THE DESCRIBED EVENT. ADDITIONALLY THE CUSTOMER DID NOT ALLOW GETINGE REPRESENTATIVE TO INVESTIGATE AND EVALUATE THE DEVICE OR TO TAKE A SAMPLE AND INVESTIGATE THE DETERGENT, THEREFORE IT COULD BE INTERPRET AS POINTING TO A POTENTIAL USER ERROR. IT IS HIGHLY UNLIKELY THAT THE DETERGENT USED BY THE CUSTOMER IS THE ONE WHICH WAS MENTIONED AND RECOMMENDED BY THE GETINGE AND MOST PROBABLY FOR THIS REASON WE HAVE NOT RECEIVED ANY SAMPLES FOR AN EVALUATION. THE DEVICE WAS INSPECTED BY THE CUSTOMER SERVICE MANAGER AND AS IT WAS STATED NO MALFUNCTION WAS FOUND THAT WOULD HAVE PLAYED A ROLE IN CAUSING THE EVENT. TAKING UNDER CONSIDERATION ALL FACTORS, THE MOST PROBABLE ROOT CAUSE OF THE CHEMICAL BURN OF THE PATIENT IS CUSTOMER USING WRONG DETERGENT. IN SUMMARY, THE DEVICE WHICH PLAYED A ROLE IN THIS EVENT WAS USED FOR PATIENT AT THE TIME OF ISSUE OCCURRENCE, DUE TO DEVICE'S INTENDED USE. WE HAVE NOT RECEIVED ANY EVIDENCE THAT THE GETINGE DEVICE AND GETINGE DETERGENT FAILED TO MEET THEIR SPECIFICATION IN THE WAY THAT COULD BE DIRECTLY INVOLVED WITH THE OCCURRENCE OF THE REPORTED INCIDENT. THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE GETINGE REPRESENTATIVE THAT THE PATIENT GOT CHEMICAL BURN AFTER USING THE BOWL WHICH WAS PREVIOUSLY DISINFECTED IN THE GETINGE'S DEVICE - TYPHOON. AFTER INCIDENT THE PATIENT WAS EXAMINED BY THE DOCTOR WHO CLASSIFIED THE INJURY AS CHEMICAL BURN. TECHNICAL SERVICE FROM THE FACILITY STATED THAT THE PRODUCT WHICH THEY PUT THE NIGHT BEFORE WAS GETINGE CLEAN FLUSHER RINSE LOT N° 11504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664734 SP6000 TYPHOON FLH GETINGE DISINFECTION AB SP-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other