BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMPC-BLOC SAF 2-14, 400ML, 2-14ML/HR+5ML/30

    MDR report key: 2982328 · Received February 22, 2013

    Report

    Report Number
    2026095-2013-00035
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    October 10, 2012
    Report Date
    January 24, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Removal / Correction Number
    02026095-05/08/2012-001-
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WAS RETURNED TO I-FLOW FOR EVAL AND INVESTIGATION. RESULTS: AT THIS TIME THE DEVICE IS PENDING EVAL. CONCLUSIONS: ON JANUARY 24, 2013, (B)(4), QC, NOTIFIED I-FLOW OF TEST RESULTS FOR A MODEL NUMBER 04440008. (B)(4) REFERENCE NUMBERS ARE AS FOLLOWS: (B)(4), BATCH: 152803; I-FLOW'S COMPLAINT NUMBER: (B)(4). ON MAY 21, 2012, I-FLOW, LLC HAD NOTIFIED THE DISTRIBUTOR, (B)(4) THROUGH A VOLUNTARY MEDICAL DEVICE FIELD SAFETY NOTICE (FSN) THAT ON-Q PUMPS C-BLOC WITH ON DEMAND BOLUS BUTTON WERE UNDER RECALL. NOTIFICATIONS WERE SENT TO (B)(4). ON FEBRUARY 12, 2013, (B)(4), I-FLOW SR. SPECIALIST, REGULATORY AFFAIRS, CONTACTED (B)(4) REGARDING THIS RECENT COMPLAINT TO DETERMINE WHY (B)(4) WAS IN POSSESSION OF A PUMP MODEL THAT IS UNDER RECALL. (B)(4) ALERTED (B)(4) TO THE FACT THAT (B)(4) HAD PROVIDED I-FLOW WITH A CERTIFICATE OF DISPOSAL FOR GOODS COLLECTED AND DESTROYED ON (B)(4) 2012 AT 10:31 PM. THE CERTIFICATE WAS FOR (B)(4) PIECES OF MODEL NUMBER 04440006 AND (B)(4) PIECES OF MODEL NUMBER 04440008. ON FEBRUARY 21, 2013 (B)(4), SUPPLY CHAIN MANAGEMENT, (B)(4) CONTACTED (B)(4) STATING THAT HE HAD TAKEN OVER THE RESPONSIBILITIES OF (B)(4) AND ASKED FOR THE RECALL INFO AND SPECIFICALLY FOR THE BATCHES INVOLVED. (B)(4) RESENT THE FIELD SAFETY NOTICE TO (B)(4) ON FEBRUARY 21, 2013. I-FLOW IS CONTINUING TO FURTHER INVESTIGATE THIS COMPLAINT WITH OUR DISTRIBUTOR, (B)(4). A F/U REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION AND EVAL ARE COMPLETE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 400 ML. FLOW RATE: 4.0 ML/HR. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: FEMORAL NERVE. DATE OF SURGERY: (B)(6) 2012. (B)(4) REPORTED PUMP FLOWED FAST. PT HAD SUDDEN ILLNESS, PROGRESSING WITH HIGH DISCOMFORT, HYPOTENSION, BRADYCARDIA 923 BPM), USE OF VASOACTIVE DRUGS. PT UNDERWENT RESUSCITATION AND HE WAS SENT TO THE ICU FOR 24 HOURS, HE HAD PROLONGED HOSPITALIZATION FOR NINE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77645 EASYPUMPC-BLOC SAF 2-14, 400ML, 2-14ML/HR+5ML/30 ELASTOMERIC PUMP MEB I-FLOW, LLC 4440008 152803

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR