BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4824511 · Received June 4, 2015

    Report

    Report Number
    8010042-2015-00230
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL OBSERVATION OF THE RETURNED EDI CATHETER SHOWED THAT IT HAD CRACKED. THE CRACK WAS FROM THE LOWERMOST FEEDING HOLE UPWARDS TO THE FOURTH HOLE. THE EDI CATHETER HAD BEEN IN USE FOR 8 DAYS. ALL MANUFACTURING PARAMETERS FOR THE EDI CATHETER WERE WITHIN SPECIFICATIONS. THERE ARE NO OTHER COMPLAINTS FROM THE SAME BATCH. NONE OF MEDICATIONS OR THE NUTRITION GIVEN THROUGH THE EDI-CATHETER IS JUDGED TO AFFECT THE EDI-CATHETER MATERIAL (B)(6). WITH THE INFORMATION AVAILABLE IT HAS NOT BEEN ABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED CRACKING OF THE EDI CATHETER. THERE WERE NO MANUFACTURING DEFECTS OR OTHER SIMILAR COMPLAINTS FOR THIS BATCH. NO SPECIFIC MEDICINE OR NUTRITION HAS BEEN DETERMINED TO AFFECT THE MATERIAL OF THE EDI CATHETER. THE EXACT TIME OF CRACKING COULD NOT BE DETERMINED BUT THE EXTENDED USE AFTER THE RECOMMENDED 5 DAYS CANNOT BE RULED OUT AS CONTRIBUTORY FACTOR. OUR CONCLUSION IN THE MATTER IS THAT THE CAUSE WAS MOST LIKELY DUE TO A COMPLEX COMBINATION OF MATERIAL PROPERTIES AND EFFECTS FROM THE SURROUNDING CHEMICAL AND BIOLOGICAL ENVIRONMENT IN THE STOMACH.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE STARTED INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PULLED OUT THE EDI CATHETER. THE EDI CATHETER HAD BEEN IN USE IN THE PATIENT FOR 8 DAYS. IT WAS OBSERVED THAT THE EDI CATHETER HAD CRACKED. THERE WAS NO PATIENT HARM. THE EDI CATHETER IS USED DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) TO DETECT THE ELECTRICAL ACTIVITY IN THE DIAPHRAGM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363485 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1