BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESEP OLIGON OXIMETRY CATHETERS

    MDR report key: 1780050 · Received August 2, 2010

    Report

    Report Number
    2015691-2010-13828
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 7, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K060093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESEP CATHETER, (16CM 8.5F 3-LUMEN), THE SUTURE LOOP AND THE BOX CLAMP WERE RETURNED FOR EVALUATION. EXAMINATION REVEALED THAT ALL THROUGH LUMENS WERE PATENT AND NO LEAKAGE WAS OBSERVED. THE CATHETER BODY WAS FOUND TO BE IN GOOD CONDITION. THERE WERE NO KINKS, PUNCTURES, TEARS OR CRACKS OBSERVED. THE CATHETER ALSO PASSED IN-VITRO CALIBRATION TESTING. THE 5 AND 7 CENTIMETER PORTS WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THERE WERE NO ABNORMALITIES CONFIRMED ON EVALUATION OF THE RETURNED CATHETER. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER AND THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. THE ROOT CAUSE FOR THE REPORTED CENTRAL LINE INFILTRATION CANNOT BE DETERMINED; HOWEVER, THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION OR MANUFACTURING DEFECT. THERE ARE POTENTIAL NON-PRODUCT RELATED CAUSES INCLUDING CATHETER DISPLACEMENT FROM THE VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESEP CATHETER WAS OPTIMALLY INSERTED VIA RIGHT INTERNAL JUGULAR, THERE WAS BLOOD RETURN, CATHETER CALIBRATED AND SQI WAS 1. AN X-RAY VERIFIED GOOD PLACEMENT. IT WAS STATED THAT THE NEXT DAY, THERE WERE NO ISSUES OBSERVED. THE FOLLOWING DAY THE PATIENT'S CONDITION REQUIRED MAXIMUM DOSE OF PRESSORS THAT WERE INFUSED THRU MEDIAL AND PROXIMAL PORT, THE DISTAL PORT HAD GOOD CENTRAL VENOUS PRESSURE WAVEFORM. PATIENT DEVELOPED INFILTRATION OF FLUIDS AND VASOPRESSORS. THE NURSE REPORTED SWELLING AND SKIN DISCOLORATION TO THE RIGHT SHOULDER, LINE WAS INTACT, CVP WAVEFORM WAS UNCHANGED FROM EARLIER. A CHEST X-RAY WAS TAKEN AND CONFIRMED OPTIMAL PLACEMENT AND INTERNAL JUGULAR AND SCV AND ULTRASOUND REVEALED THAT THERE WAS NO CLOT. INFUSION WAS STOPPED AND REGITINE WAS ADMINISTERED OVER THE AREA. LINE WAS DISCHARGED THE NEXT DAY. PRESSORS CHANGED TO ANOTHER CENTRAL LINE ACCESS WITH IMMEDIATE NEED TO TAPER DOSES TO IMPROVE MAP, DOCTOR INJECTED REGITINE TO SHOULDER AND ALL BLANCHED AREAS. CATHETER REMAINED IN PLACE AND ONLY USED DISTAL PORT FOR CVP MONITORING. CATHETER WAS DISCONTINUED AND SWELLING HAD RESOLVED AND SKIN WAS PINK. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP OLIGON OXIMETRY CATHETERS CENTRAL VENOUS OXIMETRY CATHETER DQE EDWARDS LIFESCIENCES, PR XA3820HKCDC

    Patients

    Seq Age Sex Outcome Treatment
    1