BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUINTON PERMCATH

    MDR report key: 41862 · Received October 4, 1996

    Report

    Report Number
    41862
    Event Type
    Death
    Date Received
    October 4, 1996
    Date of Event
    September 23, 1996
    Report Date
    September 24, 1996
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKEN TO SURGERY FOR INSERTION OF A CATHETER TO BE USED FOR HEMODIALYSIS. IN RECOVERY ROOM, A PORTABLE CHEST X-RAY WAS OBTAINED FOR LINE PLACEMENT. TWENTY MINS LATER THE PT DEVELOPED A SEIZURE WITH A DROP IN BP AND O2 SAT. THE SEIZURE ENDED WITHOUT REQUIRING TREATMENT. BP AND O2 SAT IMPROVED. TEN MINS LATER, BP AND RESPIRATIONS AND O2 SAT DROPPED. PT WAS INTUBATED. CARDIAC ARREST. RADIOLOGY CALLED TO SAY THE TIP OF THE CATHETER WAS PROBABLY IN THE RIGHT PLEURAL SPACE. RIGHT CHEST TUBE INSERTED. RETURN WAS SEROSANGUINOUS YIELDING FRANK BLOOD. CHEST TUBE CLAMPED AFTER 1500 CC OF FLUID REMOVED. EMERGENCY RIGHT THORACOTOMY DONE IN RECOVERY ROOM. LARGE RIGHT HEMOTHORAX WAS SEEN. THE CATHETER APPEARED TO BE EXITING THE SUPERIOR VENA CAVA. OPEN CARDIAC MASSAGE DONE. THE PT WAS TRANSFERRED TO OR. SVC PERFORATION WAS REPAIRED. THE CATHETER WAS REMOVED. DESPITE AGGRESSIVE TREATMENT, THE PT EXPIRED AT 3:20 PM. THE EQUIPMENT WAS NOT RETAINED. HOSP IS UNABLE TO DETERMINE IF IT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON PERMCATH Implant DUAL LUMEN 36 CM CATHETER LFJ QUINTON INSTRUMENT CO. UNK 874711-01/96

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death FLUOROSCOPY FOR IV ACCESS| 9/20/96 - LEFT SUBCLAVIAN LINE INSERTED UNDER