BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM

    MDR report key: 1772076 · Received July 21, 2010

    Report

    Report Number
    MW5016820
    Event Type
    Death
    Date Received
    July 21, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    I-FLOW/KIMBERLY CLARK
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B) (6) FEMALE WITH FALL AND RESULTING COMPLEX C2-III-FRACTURE, ASSOCIATED TRANSVERSE FORAMEN INJURY, MULTIPLE RIB FRACTURES, LUNG CONTUSION. PAIN FROM RIB FRACTURES LIMITING RESPIRATORY EFFORT, FELT THAT NEURAXIAL APPROACH NOT INDICATED GIVEN HIGH RIB FRACTURES -2ND ON ONE SIDE, 3RD ON THE OTHER-. TWO OPERATORS WERE STAFF TRAUMA/CRITICAL CARE SURGEONS. PROCEDURE ON RIGHT SIDE. RIB FRACTURES A BIT POSTERIOR TO MID-AXILLARY LINE. PT SUPINE POSITION. PREPPED AND DRAPED IN USUAL FASHION. LOCAL ANESTHETIC FIELD BLOCK. TWO ON-Q 10" SILVER CATHETERS PLACED WITH 12" TUNNELER IN SUBCUTANEOUS SPACE ANTERIOR AND POSTERIOR TO FRACTURES, THOUGH SMALL SKIN NICKS AT APPROX 11 RIB, SLIGHT "V" TO TRACKS TO AVOID AXILLA, COULD PALPATE TUNNELER IN SUB Q -PT NEITHER CACHECTIC NOR OBESE-. NO UNUSUAL SENSATIONS TO OPERATOR, TORQUING, "POPS." SKIN ADHESIVE AND OCCLUSIVE DRESSING PLACED AFTER PRIMING. IMMEDIATELY AFTER PLACEMENT, PT RAPIDLY DEVELOPED HEMOPTYSIS, ENDOTRACHEAL INTUBATION INDICATED. ATTEMPTS BY ANESTHESIOLOGIST UNSUCCESSFUL, CRICOTHYROIDOMY REQUIRED, TRACHEA FILLED WITH BLOOD. PT BECAME DIFFICULT TO VENTILATE, ETT PULLED BACK, COULD PASS SUCTION CATHETER BUT NO IMPROVEMENT, ETT REPLACED, LARGE CLOT AT END OF INITIAL ETT. PT EXPIRED, LIKELY FROM CLOT IN AIRWAY LEADING TO HYPOXIA AND CARDIAC ARREST. DOSE: BUPIVICAINE 0.25%. FREQUENCY: CONTINUOUS INFUSION. ROUTE: SQ. DATES OF USE: MINUTES, (B) (6)2010. DIAGNOSIS OR REASON FOR USE: PAIN FROM RIB FRACTURES. EVENT ABATED AFTER USE: NO. DO NOT BELIEVE THAT OTHER PRODUCTS CONTRIBUTED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM ON-Q PUMP, BUPIVICANE 0.25% MEB I-FLOW/KIMBERLY CLARK PENDING PENDING

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death