BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC:400ML, 1-7 M./HR SAF, + 5ML/60MIN

    MDR report key: 3202048 · Received June 27, 2013

    Report

    Report Number
    2026095-2013-00115
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR RETURN BY THE CONSUMER. HOWEVER, AT THIS TIME I-FLOW HAS BEEN UNSUCCESSFUL IN CONTACTING THE CONSUMER TO OBTAIN ANY FURTHER INFO. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED AS THE LOT INFO WAS NOT OBTAINED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, OR THE SAMPLE IS RECEIVED, I-FLOW WILL SUBMIT A F/U REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS, AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK. FILL VOLUME: 550 ML. FLOW RATE: UNK. PROCEDURE: SHOULDER SURGERY. CATHPLACE: UNK. DATE OF SURGERY: (B)(6) 2013. THE PT'S WIFE CONTACTED THE I-FLOW CLINICAL SUPPORT LINE TO INQUIRE IF SHE HAD REMOVED THE ENTIRE CATHETER. IT WAS CONFIRMED THAT IT WAS INTACT. PT'S WIFE REPORTED THE SURGERY WAS ON THURSDAY AND THE PUMP WAS REPORTED TO BE FLAT AND THEY EXPECTED IT TO RUN LONGER. THE PT HAD BEEN UNABLE TO PRESS THE BUTTON DOWN FOR A BOLUS AS IT WAS STUCK. THE PT'S WIFE DENIED THE PT EXPERIENCED ANY SIDE EFFECTS. THE HOTLINE NURSE ATTEMPTED TO COLLECT FURTHER INFO. THE PT'S WIFE STATED THAT SHE WOULD LIKE TO BE CALLED LATER, AS HER CONCERN WAS THAT HER HUSBAND WAS IN A LOT OF PAIN. SHE WAS INSTRUCTED TO RETAIN THE PUMP FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293061 ON-Q C-BLOC:400ML, 1-7 M./HR SAF, + 5ML/60MIN ELASTOMERIC PUMP MEB I-FLOW CORP. CB005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1