BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4774479 · Received May 13, 2015

    Report

    Report Number
    8010042-2015-00186
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 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 WAS TORN FROM THE LOWER-MOST FEEDING HOLE UPWARDS TO THE THIRD HOLE WHERE THE LARGEST TEAR WAS AND IT CONTINUES FROM HERE TO THE 4TH HOLE. APART FROM THE TEAR, IT WAS STILL HELD TOGETHER AND NOTHING HAD BROKEN OFF. THERE IS A NEGLIGIBLE SWELL IN THE LOWER PART BUT IN GENERAL, THE CATHETER LOOKED FINE WITH NORMAL HARDNESS. 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 NEGATIVELY. WITH THE INFO AVAILABLE, IT HAS NOT BEEN DETERMINED AS TO THE TRUE CAUSE OF THE REPORTED BREAKING OF THE EDI CATHETER. THERE WERE NO MANUFACTURING DEFECTS OR OTHER SIMILAR COMPLAINTS FOR THIS BATCH. NO SPECIFIC MEDICINE OR NUTRITION HAVE BEEN DETERMINED TO AFFECT THE MATERIAL OF THE EDI CATHETER. THERE ARE ALSO NO INDICATIONS OF MISUSE. 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

    FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 2.5 DAYS OF USE, THE EDI CATHETER BECAME PLUGGED AND THE NURSE WAS UNABLE TO FLUSH THE EDI CATHETER. THE EDI READINGS WERE UNAFFECTED. THE NURSE PULLED OUT THE EDI CATHETER WITH THE INTENTION TO CLEAR THE BLOCKAGE. UPON PHYSICAL INSPECTION OF THE EDI CATHETER, THE DISTAL END WAS DISCOLORED AND SPLIT. 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).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312816 SERVO-I CBK CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1