BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3760313 · Received April 20, 2014

    Report

    Report Number
    1226348-2014-11402
    Event Type
    Injury
    Date Received
    April 20, 2014
    Date of Event
    February 20, 2012
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED, TO BE POPULATED AS SERIOUS INJURY.

    Description of Event or Problem · 1

    (B)(6) REPORTED THAT "PATIENT HAD AN AP03050M PUMP. DURING A REFILL (USING A CODMAN REFILL KIT), THE NEEDLE WAS CONNECTED TO TUBING WITH EMPTY SYRINGE. NURSE INSERTED NEEDLE INTO SEPTUM AND A RETURN VOLUME OF 15.5CC WAS COLLECTED. THE LINE WAS CLAMPED AND THE SYRINGED WITH 15.5MLS OF FLUID WAS REMOVED (EMPTY BARREL SYRINGE USED/NO PLUNGER). SHE THEN ATTACHED A 20CC SYRINGE WITH DRUG (DILAUDID- 6MG/ML, BUPIVICANE 17.5MCG/ML, PRIALT 2.5MCG/ML). WHEN SHE ATTACHED THE FIRST 20ML SYRINGE SHE BEGAN INJECTING (5 IN 1 OUT METHOD). SHE CLAMPED THE LINE AND COULD NOT REMOVE SYRINGE, DR (B)(6) CAME IN, AT THAT POINT, THE PATIENT WAS REPORTING NUMBNESS IN THE LEGS AND FEELING OF AIR AROUND HIS STOMACH. AT THAT POINT, THEY UNCLAMPED THE TUBING AND ASPIRATED THE 20CC OF DRUG MIXTURE. PATIENT WAS MOVED TO THE ER FOR MONITORING AND THEN ADMITTED TO PULMONARY ICU FOR OBSERVATION. HE DID NOT GO INTO RESPIRATORY DEPRESSION BUT NUMBNESS WAS REPORTED AS HIGH AS HIS NIPPLE LINE. THE NEXT DAY (TUESDAY) THEY REMOVED THE PUMP AND CATHETER AND REPLACED IT WITH A MEDTRONIC PUMP. PATIENT WAS COVERED WITH IV DILAUDID FOR PAIN. THIS WAS REPORTED BY (B)(6). THE PUMP IS WITH RISK MANAGER - (B)(4). (B)(6) WILL CONTACT RISK MANAGER REGARDING PUMP RETURN. (B)(6) 2012 COMPLAINT WAS RE-OPENED AS THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED, TO BE POPULATED AS SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239174 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK B0323

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention