BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDI CATHETER ENFIT

    MDR report key: 9842303 · Received March 17, 2020

    Report

    Report Number
    8010042-2020-00156
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    December 29, 2019
    Report Date
    March 17, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED AND CONSISTS OF EVALUATION OF THE RECEIVED INFORMATION THAT INCLUDES PICTURES AND ANSWERS FROM THE HOSPITAL TO OUR INFORMATION REQUESTS. IT HAS NOT BEEN POSSIBLE TO RETURN THE EDI CATHETER FOR INVESTIGATION DUE TO PREVAILING HEALTH AND SAFETY CONDITIONS. THE EDI CATHETER WAS IN USE FOR 6 DAYS AND ITS NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) FUNCTIONING WAS WITHOUT ANY PROBLEM. ACCORDING TO THE HOSPITAL, THE EDI CATHETER WAS NOTED TO BE LEAKING AND IT WAS THEREFORE REPLACED. ITS EXAMINATION AFTER REMOVAL SHOWED THAT IT HAD A 2MM LONGITUDINAL SPLIT AT 13.5 CM AND BEYOND THIS IT HAD A DRIED WHITE SUBSTANCE. DURING FLUSHING IN THE LAB EXAMINATION WHILE MANUALLY HOLDING THE SPLIT CLOSED IT WAS FOUND THAT THE EDI CATHETER HAD OCCLUDED AT THE DISTAL END. THE HOSPITAL STATED THAT NO LEAK INTO PATIENT OR CHOCKING WAS NOTED BEFORE THE REMOVAL OF THE EDI CATHETER. THE HOSPITAL ROUTINES OF FLUSHING THE EDI CATHETERS IS NOT AFTER FEEDING BUT TO FLUSH EVERY AFTER ADMINISTRATION OF MEDICINE. THE HOSPITAL WAS UNSURE IF THE ROUTINE WAS FOLLOWED. THE CAUSE OF THE SPLIT AND WHEN IT OCCURRED HAS NOT BEEN DETERMINED. THE OCCLUSION WAS MOST PROBABLY CAUSED BY NON-FLUSHING OF THE EDI CATHETER AFTER ADMINISTRATION. THE EDI CATHETER WAS IN THE PATIENT FOR 6 DAYS BUT THE RECOMMENDED MAXIMUM DURATION OF USE IS 5 DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER WAS PLACED AS AN OG-TUBE IN THE PATIENT AND WAS BEING USED FOR NAVA AND FEEDING. THE PATIENT WAS RECEIVING CALCIUM SUPPLEMENTATION VIA THE CATHETER. A LEAK WAS DISCOVERED AND THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER ONE. THE HOSPITAL EXAMINED THE CATHETER AND DISCOVERED THAT 2 MM LONGITUDINAL SPLIT AT 13.5 CM BEYOND WHICH THE CATHETER WAS COMPLETELY OCCLUDED WITH A DRIED WHITE SUBSTANCE THOUGHT TO BE A DRIED CALCIUM SUPPLEMENT. THE HOSPITAL STATED THAT THEY HAD PREVIOUSLY ATTEMPTED TO FLUSH THE OCCLUDED CATHETER WITH EXCESSIVE PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305191 EDI CATHETER ENFIT GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 6FR/49CM 92257276

    Patients

    Seq Age Sex Outcome Treatment
    1