BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAH ELITE KTI 13.5FR 16CM CE

    MDR report key: 3982923 · Received July 14, 2014

    Report

    Report Number
    3009211636-2014-00011
    Event Type
    Other
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 9, 2014
    Manufacturer
    COSTA RICA COVIDIEN MANUFACTURING
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THAT AFTER COMPLETION OF APHERESIS TREATMENT, THE CATHETER WAS CAPPED. THE PT THEN COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH. THE PT BECAME ANXIOUS, HOWEVER, THE PT WAS STILL ALERT AND CONSCIOUS. PT WAS HYPOTENSIVE. NURSE CALLED A CODE TO GET HELP. PULSE OX WAS 80%. BLOOD GAS WAS DRAWN AND PAO2 WAS LESS THAN 40. PT WAS THEN IN-TUBATED. WHILE IN-TUBATING THE PT, THE DIALYSIS CATHETER WAS PULLED. AFTER PT WAS IN-TUBATED. PT WAS THEN TRANSFERRED FROM MEDICAL OFFICE BLDG TO ED AT THE HOSPITAL. THEN PT WAS TRANSFERRED TO ICU AND PLACED ON ECMO. UPON PARENTAL REQUEST, PT WAS TRANSFERRED TO (B)(6) MEDICAL CENTER. MAHURKAR CATHETER HAD BEEN USED FOR A COUPLE OF 8 TREATMENTS OF APHERESIS FOR GUILLAIN-BARR SYNDROME. THE CUSTOMER WOULD LIKE THE CATHETER CHECKED FOR DEFECT TO RULE OUT AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410056 MAH ELITE KTI 13.5FR 16CM CE DIALYSIS CATHETER MSD COSTA RICA COVIDIEN MANUFACTURING 8888212216 325539X

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L| R