BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FMS DUP PUMP

    MDR report key: 3008755 · Received March 18, 2013

    Report

    Report Number
    1221934-2013-00065
    Event Type
    Injury
    Date Received
    March 18, 2013
    Report Date
    March 6, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    E521631
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO DOCUMENT A HISTORICAL EVENT WHICH WAS BROUGHT TO MITEK'S ATTENTION VIA A PUBLISHED CASE STUDY REPORT DATED IN 2010. IN THE PAPER'S CASE 'DISCUSSION," THE SURGEON AUTHORS COME TO THE CONCLUSION THAT THERE IS A "NEED FOR PHYSICIANS AND SUPPORT STAFF TO BE AWARE OF THE AMOUNT OF FLUID BEING USED IN ANY ARTHROSCOPY CASE." THEY FURTHER REMARK THAT: "PHYSICAL AND PHYSIOLOGIC SIGNS OF FLUID EXTRAVASATION SHOULD BE MONITORED THROUGHOUT THE ENTIRE PROCEDURE", AND, "THIS EXPERIENCE HAS LED US TO ALTER OUR ORDER OF SURGICAL PROCEDURE. THE SURGEON AUTHORS DO NOT ATTRIBUTE THE ISSUE TO ANY SHORT COMINGS OR DEFECT OF THE MITEK PUMP, BUT RATHER TO THE LACK OF MONITORING FROM BY THE SURGEON AND STAFF OF BOTH THE FLUID VOLUME BEING USED AND THE PHYSICAL AND PHYSIOLOGIC SIGNS AS THEY WERE PRESENTING. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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

    PATIENT ISSUE - ABDOMINAL COMPARTMENT SYNDROME: MITEK RECEIVED A PUBLISHED CASE REPORT (ARTHROSCOPY 2010, 26, 128-130) REPORTING COMPLICATIONS OF ABDOMINAL COMPARTMENT SYNDROME DERIVED FROM "FLUID MANAGEMENT" DURING A HIP ARTHROSCOPY. THE SURGEON AUTHORS IN THEIR CASE STUDY REPORT THAT A PATIENT PRESENTED WITH A LONG-STANDING HISTORY OF RIGHT HIP AND GROIN PAIN THAT WAS REFRACTORY TO CONSERVATIVE MANAGEMENT. FEMORAL ACETABULAR IMPINGEMENT WAS DIAGNOSED, AND SURGERY WAS SCHEDULED. DURING THE SURGERY A MITEK FMS DUO PUMP WAS USED FOR THE FLUID MANAGEMENT; PRESSURE WAS SET TO 40 MM HG, AND LAVAGE WAS ACTIVATED INTERMITTENTLY, WHICH RAISED THE PRESSURE TO 60 MM HG FOR 2 MINUTES; SURGERY TIME WAS 95 MINUTES WITH THE PATIENT RECEIVING 800 ML OF LACTATED RINGER SOLUTION, AND THE PATIENT'S CORE TEMPERATURE REMAINED STEADY THROUGHOUT THE PROCEDURE. AT THE END OF THE SURGERY, THE PATIENT WAS UN- DRAPED, AND IT IS AT THIS TIME THAT THEY NOTED THAT THE PATIENT'S ABDOMEN WAS EXTREMELY DISTENDED. AT THIS POINT THE GENERAL SURGERY TEAM WAS CONSULTED AND NOTED ELEVATED BLADDER PRESSURE (42 MM HG) AND INCREASED PEAK INSPIRATORY PRESSURE, PREVENTING EXTUBATION. ABDOMINAL COMPARTMENT SYNDROME WAS DIAGNOSED, AND A DIAGNOSTIC PERITONEAL LAVAGE WAS ATTEMPTED AND FAILED. AN EMERGENT EXPLORATORY LAPAROTOMY WAS PERFORMED, WHICH YIELDED 1,200 ML OF SEROSANGUINOUS FLUID WITHIN THE ABDOMINAL CAVITY. THE RETROPERITONEUM WAS DISTENDED AND BOGGY WITH AN OBVIOUS FLUID TRACK ALONG THE ILIOPSOAS MUSCLE AND ILIAC VESSELS ON THE RIGHT SIDE. THE ABDOMEN WAS LEFT OPEN, AN A WOUND VACUUM WAS PLACED. A STAGED PRIMARY CLOSURE OF THE PATIENT'S ABDOMEN WAS PERFORMED ON POSTOPERATIVE DAY 3. THE PATIENT WAS DISCHARGED 3 DAYS LATER IN STABLE CONDITION. AT THE MOST RECENT FOLLOW-UP (HISTORICALLY SPEAKING) WITH THE SURGEON IT WAS NOTED THAT THE PATIENT WAS STILL FOLLOWING UP WITH A GENERAL SURGEON FOR ABDOMINAL COMPLAINTS RELATED TO HIS INCISION AND ABDOMINAL COMPARTMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111428 MITEK FMS DUP PUMP FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR