BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2960313 · Received February 8, 2013

    Report

    Report Number
    2026095-2013-00029
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    March 1, 2011
    Report Date
    January 11, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED. RESULTS: A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED WITH THE INFORMATION PROVIDED. PHONE NUMBER GIVEN BELONGED TO THE INITIAL REPORTER. USER FACILITY, PHYSICIAN'S INFORMATION AND ADDRESS OF PT WAS REQUESTED BUT NOT PROVIDED. CONCLUSIONS: TO DATE THE INITIAL REPORTER HAS BEEN UNRESPONSIVE TO I-FLOW'S REQUEST FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.5%, FILL VOLUME: UNKNOWN, FLOW RATE: 2.0 ML/HR, PROCEDURE: HERNIA REPAIR, CATHPLACE: UNKNOWN. ADVERSE EVENT: PT'S FIANCE REPORTED THAT THE PT 48 HOURS INTO THE INFUSION THE PT BEGAN "SWEATING, HAD NUMBNESS IN HIS HANDS AND FEET, DIZZINESS, LIGHT-HEADEDNESS, AND BLURRED VISION". THE PT HAD AN ON-Q: FIXED FLOW RATE PUMP. THEY WENT TO THE E.R., AND THE INFUSION WERE CONTINUED UNTIL IT WAS COMPLETE. PT'S FIANCE ALLEGED THAT THE PT BECAME VERY ILL AND HAD DRUG-INDUCED (B)(4). SHE STATED THAT SHE DID NOT THINK ANYTHING WAS GOING WRONG WITH THE PUMP AT THE TIME. THE PUMP IS NOT AVAILABLE FOR RETURN. PT CONTACT: YES. ADVERSE EVENT: YES, EVENT DATE: (B)(6) 2011 (DATE WAS UNSPECIFIED), HOSPITAL LOCATION AND PHYSICIAN WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53405 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN NAME AND DOSAGE| SUPPLEMENTAL PAIN MEDICALTION (NARCOTIC)