BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1029623 · Received April 10, 2008

    Report

    Report Number
    2026095-2008-00041
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 10, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. THE INFORMATION CONTAINED HEREIN IS BAED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT A PATIENT EXPERIENCED PVC'S DURING THE USE OF TWO PAIN PUMPS SIMULTANEOUSLY. THE PUMPS WERE IMMEDIATELY CLAMPED OFF WHEN INCIDENT WAS IDENTIFIED. DR DOESN'T THINK THE PAIN PUMPS CAUSED THIS INCIDENT. NO PUMP MALFUNCTION WAS REPORTED. IT IS A POSSIBLE REACTION BUPIVACAINE. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PATIENT STARTED HAVING PVC'S 3-4 DAYS POST-OP. NURSE WAS INSTRUCTED TO CLAMP THE PUMPS WHICH WERE CLAMPED UNTIL PVC'S WENT AWAY (RIGHT AFTER THEY PULLED THE CENTRAL LINE FROM THE ATRIAL), PHARMACY CONCERNED ON-Q CAUSED THIS DUE TO SIDE EFFECTS WITH BUPIVACAINE, BUT DR. DOESN'T THINK ON-Q CAUSED THIS. FILL VOLUME 390 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM023-A 7C2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PN 5001576| 120ML BUPIVACAINE 0.25%| 1ML/HR.| MODEL P100X1| ON-Q PAINBUSTER| LOT 622085