BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC: 400ML, 5ML/HR + 5ML/60 MIN ONDEMAND

    MDR report key: 2833559 · Received October 29, 2012

    Report

    Report Number
    2026095-2012-00257
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K023318
    Removal / Correction Number
    2026095-05/08/2012-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE INVOLVED IN THE INCIDENT IS REPORTED TO BE AVAILABLE AND RETURNING TO I-FLOW. IT IS CURRENTLY PENDING RECEIPT. RESULTS: THE PRODUCT USED (CB003) IS UNDER RECALL, THE START DATE OF THE RECALL WAS 05-08-2012. CONCLUSIONS: AFTER BEING ADVISED OF THE INCIDENT I-FLOW CONTACTED OUR DISTRIBUTOR (B)(4), AND (B)(4) HAD ONE OF THEIR EMPLOYEES PERSONALLY VISIT (B)(6), AND SPEAK TO THE PHARMACIST. THE PHARMACIST WAS ADVISED THAT THE PRODUCT USED IN THIS INCIDENT IS CURRENTLY UNDER RECALL AND REQUESTED ALL REMAINING INVENTORY. OUR DISTRIBUTOR (B)(4) PHYSICALLY COLLECTED FOUR (4) UNITS FROM (B)(6) ON (B)(4) 2012 AND CURRENTLY HAVE THEM IN QUARANTINE. WE ARE CURRENTLY AWAITING THE RETURNED PUMP FROM THE PATIENT. PATIENT STATES THAT HE WILL RETURN THE UNIT DIRECTLY TO THE HOSPITAL FOR CREDIT. WE HAVE REQUESTED OUR DISTRIBUTOR, (B)(4), TO WORK WITH (B)(6) TO RETURN THE UNIT TO I-FLOW. PATIENT RETURNED A CALL TO I-FLOW STATING THAT HE CALLED THE ANESTHESIOLOGIST AND DR. (B)(6), WHO SPOKE WITH HIS COLLEAGUES AND THE PHARMACY. THEY WERE AWARE OF THE RECALL BUT STATED THAT THIS PARTICULAR PUMP WAS NOT PART OF THE RECALL AND TO USE THE PUMP WITHOUT USING THE BUTTON. NO ADVERSE EVENT REPORTED. START OF INFUSION: APPROXIMATELY (B)(6) 2012 AROUND 12 PM. END OF INFUSION: UNKNOWN. OUR CONTACT FOR THE HOSPITAL: (B)(6).

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 400ML. FLOW RATE: 5ML. PROCEDURE: SHOULDER REPLACEMENT. CATHPLACE: UNKNOWN. THE PATIENT CALLED AND STATED THAT HE HAS AN ONDEMAND (CB003) PUMP. HE STATED THAT THE BOLUS BUTTON HAS BEEN STUCK IN THE DOWN POSITION FOR THE LAST HOUR WITH THE ORANGE INDICATOR AT THE TOP. PATIENT HAD PUSHED IT ONE OTHER TIME IN THE CAR ON THE WAY HOME. THE BUTTON WAS STUCK DOWN AND THEN THE PATIENT UNKINKED THE TUBING AND THE BUTTON POPPED BACK UP. PATIENT WAS NOTIFIED BY I-FLOW THAT THIS PUMP HAS BEEN VOLUNTARILY RECALLED AND INSTRUCTED TO CLOSE THE CLAMP. PATIENT WAS ALSO INSTRUCTED TO NOTIFY THE ANESTHESIOLOGIST OF THE RECALL, THE BUTTON ISSUE, AND TO SAVE THE PUMP FOR RETURN SO THAT I-FLOW CAN INSPECT IT. PATIENT DENIES SYMPTOMS OF LA TOXICITY AND PATIENT'S CURRENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC: 400ML, 5ML/HR + 5ML/60 MIN ONDEMAND ELASTOMERIC PUMP MEB I-FLOW LLC CB003 142644

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR