BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4580 FMS DUO+ PUMP/SHAVER COMBO

    MDR report key: 4122818 · Received September 26, 2014

    Report

    Report Number
    1221934-2014-00426
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 11, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFECTS THAT ADVERSELY AFFECT THE FUNCTION OF THE DEVICE HAVE BEEN IDENTIFIED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DETERMINE THE ROOT CAUSE FOR THE FAILURE REPORTED. FOLLOWING SERVICE ACTIVITIES WERE CARRIED OUT: MECHANICAL UPGRADE PERFORMED. PNEUMATIC CIRCUIT CHECKED. UNIT CLEANED; 8-HOUR ENDURANCE TEST CARRIED OUT. UNIT CALIBRATED NEWLY. FUNCTIONAL TEST ACC. TO TEST PROCEDURE COMPLETED. ELECTRICAL SAFETY TEST ACC. TO (B)(4) COMPLETED. HIPOT TEST COMPLETED. FUNCTIONAL TEST PERFORMED. NO OTHER COMPLAINTS HAVE BEEN REPORTED ON THIS SERIAL NUMBER. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. DEVICE EVAL: IN PROCESS.

    Description of Event or Problem · 1

    ARTHROSCOPIC DECOMPRESSION,CLAVIKELRESECTION AND CUFF TEAR REPAIR SURGERY TIME 2,5 HOUR NACL(FLUID) AROUND 20 LITRE A LOT OF RED BUTTON ON THE PEDAL (INCREASE PRESSURE) WAS USED DURING THE SURGERY. AFTER THE SURGERY WHEN THEY UNDRAPED THE PATIENT THEY NOTICED THAT THE PATIENT WAS SWOLLEN ACROSS THE CHEST AND NECK AND ARM THE ANAESTHESIOLOGIST DECIDES THAT HE CANNOT EXTUBATE THE PATIENT THE PATIENT HAD TO BE PLACED AT IVA TO SWELL OF BEFORE EXTUBATION 3 HOURS AFTER SURGERY THE PATIENT WAS OK TO GO TO THE WARD.

    Description of Event or Problem · 1

    ARTHROSCOPIC DECOMPRESSION, CLAVIKELRESECTION AND CUFF TEAR REPAIR SURGERY TIME 2,5 HOUR NACL(FLUID) AROUND 20 LITRE A LOT OF RED BUTTON ON THE PEDAL (INCREASE PRESSURE) WAS USED DURING THE SURGERY. AFTER THE SURGERY WHEN THEY UNDRAPED THE PATIENT, THEY NOTICED THAT THE PATIENT WAS SWOLLEN ACROSS THE CHEST AND NECK AND ARM; THE ANAESTHESIOLOGIST DECIDES THAT HE CANNOT EXTUBATE THE PATIENT; THE PATIENT HAD TO BE PLACED AT IVA TO SWELL OF BEFORE EXTUBATION 3 HOURS AFTER SURGERY. THE PATIENT WAS OK TO GO TO THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601407 4580 FMS DUO+ PUMP/SHAVER COMBO FMS EQUIPMENT SYSTEMS HRX DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R