BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP 270ML, 4ML/HR (2+2 DUALSITE SILVERSOAKER

    MDR report key: 3946656 · Received July 7, 2014

    Report

    Report Number
    2026095-2014-00110
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED NOT TO BE AVAILABLE FOR ANALYSIS. THE LOT NUMBER WAS REQUESTED BUT REPORTED TO BE UNAVAILABLE. THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND THE STERILIZATION CERTIFICATION COULD NOT BE OBTAINED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE CATHETERS WERE NOT RETURNED TO I-FLOW FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. THE DIRECTIONS FOR USE PROVIDE A WARNING FOR CATHETER REMOVAL: WARNING: REMOVE CATHETER AS SOON AS INFUSION IS COMPLETE TO REDUCE RISK OF INFECTION AND DIFFICULTY REMOVING CATHETER. BASED ON THE INFORMATION IT IS UNKNOWN WHEN THE CATHETERS WERE REMOVED FROM THE PATIENT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    FILL VOLUME: UNK, FLOW RATE: 4 ML/HR, PROCEDURE: THORACIC SURGERY, CATHPLACE: UNK. (PLEASE REFERENCE 2026095-2014-00109/14-00481, AND 2026095-2014-00111/14-00483). A SALES REPRESENTATIVE WAS NOTIFIED BY A SURGEON OF 3 PATIENTS THAT EXPERIENCED INFECTIONS POST-THORACIC SURGERIES. IT WAS REPORTED THAT A PATIENT EXPERIENCED A CATHETER SITE INFECTION MANIFESTED BY EMPYEMA POST-THORACIC SURGERY WHILE USING AN I-FLOW CATHETER. THE EXACT TYPE OF CATHETER USED WAS UNKNOWN BUT WAS EITHER A 5 INCH OR 7.5 INCH CATHETER. TREATMENT AND PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394687 ON-Q PUMP 270ML, 4ML/HR (2+2 DUALSITE SILVERSOAKER CATHETER, CONDUCTION, ANETHETIC BSO I-FLOW, LLC P400X4D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other