BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS DUO+ PUMP/SHAVER COMBO

    MDR report key: 3760103 · Received April 18, 2014

    Report

    Report Number
    1221934-2014-00142
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    October 18, 2013
    Report Date
    October 21, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PUMP WAS RECEIVED AND EVALUATED. THE REPORTED FAILURE COULD NOT BE VERIFIED AND NO FAULT WAS FOUND ON THE PUMP. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE FOR THE USER TO HAVE EXPERIENCED THIS FAILURE COULD NOT BE DETERMINED. THIS DEVICE HAS BEEN DISCARDED. AT THIS TIME, THERE IS NO FURTHER ACTION WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP; AFTER 29 MINUTES INTO THE OPERATION THE PRESSURE ON THE FMS PUMP WENT FROM 40 TO 110. THE PATIENT WAS NOT AFFECTED, BUT THE PRESSURE DID BUILD IN THE PATIENTS SHOULDER AND THERE WAS A LOT OF SWELLING. HE FINISHED THE CASE SHORTLY AFTER, AND THE ISSUE DID NOT HAPPEN AGAIN. SINCE THEN, THE HOSPITAL HAS PURCHASED A NEW FMS PUMP AND THERE HAVE BEEN NO PROBLEMS. AS REPORTED BY THE SERVICE CENTER; THIS WAS BOOKED IN THE (B)(4) 2013 AND REPAIRED; RETURNED (B)(4) HOSPITAL HAVE JUST CALLED AND GOT EXACTLY THE SAME PROBLEMS WITH IT. PLEASE TRANSFER THE LOAN PUMP THEY HAVE ON JOB 448038 ONTO THIS REPAIR REQUEST. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED BY OUR SALES REP ON (B)(4) 2014; THE PROCEDURE WAS EXTENDED FOR LESS THAN 30 MINUTES. THERE WERE NO CONCERNS FROM THE SURGEON REGARDING THE OUTCOME OF THE PATIENT, AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE WITH NO IMPAIRMENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237523 MITEK FMS DUO+ PUMP/SHAVER COMBO FMS EQUIPMENT SYSTEMS HRX DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1