BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PICC SOLO 5 FR DL, MAXIMAL BARRIER TRAY WITH MI, SHERLO

    MDR report key: 1772237 · Received July 22, 2010

    Report

    Report Number
    3006260740-2010-00199
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 13, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K0702230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    PROCEDURE WAS VERY STRAIGHT FORWARD, CATHETER EASILY THREADED INTO SVC. UPON COMPLETION OF PROCEDURE, PT C/O SOB, PT'S HEAD WAS LOWER AND HE CONTINUED TO COMPLAINT OF SOB, HEART RATE 80, I ASKED FOR A B/P, PT CONTINUED TO DETERIORATE OVER THE NEXT 2-3 MINUTES UNTIL A FULL CODE WAS CALLED. ONLY MEDICATION GIVEN WAS LIDOCAINE 1%, 4CC SUBQ AT INSERTION SITE. CODE TEAM SUSPECTED HE HAD THROWN A PE, HE WAS TRANSFERRED TO ICU. (WHEN DID REACTION OCCUR): PT STARTED COMPLAINING OF SOB AFTER PICC WAS IN POSITION AND CATHETER HAD BEEN FLUSHED. HE CONTINUED TO COMPLAIN OF SOB AND I THEN ELEVATED HIS HEAD TO 45 DEGREES AGAIN, AND CHECKED HIS PULSE, AT THAT TIME, THE CHARGE NURSE CAME IN AND I ASKED HER TO CHECK HIS B/P AND TOLD HER HE WAS HAVING PROBLEMS, SHE IMMEDIATELY CALLED FOR O2 AND THE PT JUST CONTINUED TO DETERIORATE TO A FULL BLOWN CODE IN A MATTER OF SECONDS. NOTHING WAS USED EXCEPT WHAT WAS IN THE KIT. THE FIRST IMPRESSION WAS A PE, WHICH WAS RULED OUT, THEN THEY SUSPECTED AN AIR EMBOLUS, WHICH I THINK WAS LATER RULED OUT. HE WAS GETTING THE PICC PRE-OP FOR AN INFECTED KNEE PROSTHESIS, HIS SURGERY WAS DELAYED DUE TO THE CODE. HERE IS WHAT THE PHYSICIAN PUT IN HIS NOTE LATER: ON JUNE 23, HE HAD A PICC LINE PLACED AND IMMEDIATELY AFTER THIS WAS FOUND TO BE UNRESPONSIVE AND HAVING SIGNIFICANT RESPIRATORY DISTRESS REQUIRING INTUBATION. DIFFERENTIAL DIAGNOSIS INCLUDES TRANSIENT AIR EMBOLISM. INITIALLY, PT DID NOT EXPERIENCE ANY HEMODYNAMIC COMPROMISE AND REMAINED WELL OXYGENATED BEFORE AND AFTER EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PICC SOLO 5 FR DL, MAXIMAL BARRIER TRAY WITH MI, SHERLO LJS C. R. BARD INC. (BASD) REUE0405

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention