BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO I

    MDR report key: 3724712 · Received February 27, 2014

    Report

    Report Number
    3008355164-2014-00036
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 1, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EDI CATHETER WAS REMOVED FROM THE PATIENT PRIOR TO SENDING THE PATIENT TO THE ACUTE CARE FLOOR, IT WAS NOTICED THAT THE WIRES WERE EXPOSED AND THE REMAINDER OF THE EDI CATHETER WAS MISSING. THE VENTILATOR HAD 2 DAYS EARLIER BEEN DISCONNECTED FROM THE PATIENT BUT THE EDI CATHETER HAD BEEN LEFT INTUBATED IN THE PATIENT FOR FEEDING. THE REMOVAL OF THE EDI CATHETER WAS DONE AFTER 8 DAYS. THE HOSPITAL REMOVED SOME OF THE EDI CATHETER PIECES BY ENDOSCOPE. THE REMAINING FRAGMENTS PASSED OUT NATURALLY BUT THEY WERE NOT RECOVERED. THE PATIENT WAS DISCHARGED AND IS DOING WELL. (B)(4).

    Description of Event or Problem · 1

    THE RETURNED EDI CATHETER WAS DISCOLORED AND HAD CRACKED WITH ELECTRODE WIRE HANGING BUT ALL WERE INTACT AND NONE WAS MISSING. THE LOWEST PART OF THE CATHETER OF ABOUT 5 CM CONTAINING ALL THE FEEDING HOLES WAS MISSING. THE EVALUATION OF MEDICINES AND NUTRITION THAT WERE ADMINISTERED THROUGH THE EDI CATHETER FOUND NONE OF THEM THAT COULD AFFECT THE MATERIAL OF THE EDI CATHETER. A TEST OF AMIODARONE FOUND THAT IT DOES NOT AFFECT THE MATERIAL OF THE EDI CATHETER. ONE OF THE MEDICINES WAS LISTED AS COULD AFFECT THE PH VALUES IN THE STOMACH BUT IT IS UNKNOWN TO WHAT EXTENT. THE EDI CATHETER MATERIAL PARAMETERS WERE ALL WITHIN THE SPECIFIED LIMITS AND THERE ARE NO OTHER COMPLAINTS RELATED TO THIS BATCH. THIS INVESTIGATION WITH THE INFORMATION AVAILABLE HAS NOT DETERMINED THE TRUE CAUSE OF THE BREAKING OF THE EDI CATHETER BUT 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. 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. THERE IS ALSO NO INDICATION OF MISUSE ALTHOUGH THE EDI CATHETER WAS USED FOR 8 DAYS WHICH IS 3 DAYS MORE THAN THE RECOMMENDED TIME OF USAGE OF 5 DAYS. WHETHER OR NOT THE LONGER USAGE TIME CONTRIBUTED TO THE BREAKAGE HAS NOT BEEN DETERMINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122253 SERVO I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Life Threatening