BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP 400ML, 4ML/HR (2+2 DUAL SITE)

    MDR report key: 4142573 · Received September 30, 2014

    Report

    Report Number
    2026095-2014-00189
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL NOT BE RETURNED FOR AN ANALYSIS. THE LOT NUMBER WAS RECEIVED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AS NO DEVICE WAS AVAILABLE FOR AN EVAL, NO METHODS WERE PERFORMED AND RESULTS CANNOT BE OBTAINED. PER THE DHR REVIEW THE LOT MET THE PROCESS SPECS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR AN EVAL, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. IT WAS REPORTED BY THE REPORTER THAT THE PUMP WAS RESTARTED APPROX 4 HOURS LATER WITH NO FURTHER SIGNS OR SYMPTOMS. MULTIPLIABLE ATTEMPTS HAVE BEEN MADE TO GATHER ADD'L INFO WITHOUT SUCCESS. SHOULD ADD'L INFO PERTINENT TO THIS EVENT BECOME AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW UP REPORT. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: 400ML. FLOW RATE: 4ML/HR. PROCEDURE: BILATERAL BREAST SURGERY. CATHPLACE: NOT PROVIDED. DATE OF SURGERY: (B)(6) 2014. AN INCIDENT OF METALLIC TASTE IN PT'S MOUTH AND SEROSANGUINOUS FLUID LEAKING AT THE CATHETER SITE WAS REPORTED TO THE PRODUCT SUPPORT LINE NURSE. ON (B)(6) 2014 AT APPROX 4:30AM THE PT WAS ADVISED TO CLOSE THE WHITE CLAMPS OF EACH CATHETER AND CONTACT HER SURGEON. AFTER THE PT CONSULTED WITH HOSP STAFF THE TUBING WAS UNCLAMPED AND INFUSION WAS RESTARTED AT APPROX 8:30AM ON (B)(6) 2014. NO OTHER SIGNS AND SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608122 ON-Q PUMP 400ML, 4ML/HR (2+2 DUAL SITE) ELASTOMERIC PUMP MEB I-FLOW, LLC P400X4D 0201434223

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other DRUG: 0.5% BUPIVACAINE