BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINOCAN

    MDR report key: 1396975 · Received May 28, 2009

    Report

    Report Number
    2523676-2009-00038
    Event Type
    Death
    Date Received
    May 28, 2009
    Date of Event
    May 22, 2009
    Report Date
    May 27, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K820047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS: 61018945, 61034767, 61033656. ADDITIONAL DEVICE MANUFACTURE DATES: 10/2008, 01/2009, 01/2009. SAMPLES OF THE REPORTED KIT LOTS HAVE NOT BEEN MADE AVAILABLE TO MANUFACTURER TO BE EVALUATED. AT THIS TIME B. BRAUN HAS CONDUCTED A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD FILES FOR THE REPORTED LOTS, ALONG WITH THE APPROPRIATE STERILIZATION RECORDS FOR EACH LOT. NO ABNORMALITIES WERE OBSERVED WHICH COULD HAVE POTENTIALLY RELATED TO THE REPORTED INCIDENTS. ALL REMAINING INVENTORY FROM THE REPORTED LOT NUMBER 61038549 WAS 100% INSPECTED FOR SEAL INTEGRITY AND NO ABNORMALITIES WERE NOTED. B. BRAUN IMMEDIATELY NOTIFIED THE MANUFACTURER OF THE LIDOCAINE AND EPINEPHRINE, HOSPIRA, THE MANUFACTURER OF THE POVIDONE IODINE, APLICARE, AND THE MANUFACTURER OF THE SPINOCAN NEEDLE. VERBAL RESPONSE RECEIVED FROM APLICARE INDICATES THAT ALL DEVICE HISTORY RECORDS FOR EACH LOT OF POVIDONE IODINE CONTAINED IN THE IDENTIFIED KITS WERE REVIEWED AND NO ABNORMALITIES WERE IDENTIFIED. ALL OTHER KIT COMPONENT MANUFACTURERS HAVE BEEN OR CONTINUE TO BE CONTACTED. B. BRAUN HAS RECEIVED NO OTHER REPORTS OF THIS NATURE AGAINST ANY MARKETED PRODUCTS. AT THIS TIME WE ARE AWAITING ADDITIONAL INFORMATION FROM THE FACILITY. WHILE ALL RECORDS REVIEWED THUS FAR DO NOT INDICATE THAT THE B. BRAUN PRODUCT CONTRIBUTED TO THIS EVENT, THE INVESTIGATION IS ONGOING. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: INFORMATION FROM RISK MANAGER, IN 2009, AT 8:45P ET VIA ON CALL.: PRODUCT WAS USED TO ADMINISTER FENTANYL AND DURAMORPH FOR LABOR AND DELIVERY PAIN RELIEF TWO DAYS PRIOR, TO TWO PATIENTS, 2 TRAYS USED, 1 HOUR APART. BOTH WOMEN HAD "NORMAL DELIVERY". MEDICATION USED FROM B. BRAUN TRAY - PROBABLE LIDOCAINE SKIN WHEAL - ADDITIONAL INFORMATION PENDING. AT 8AM THE NEXT DAY, BOTH PATIENTS DEVELOPED SEVERE NAUSEA, VOMITING, SEIZING, PLACED ON VENTILATORS, TRANSFERRED TO ANOTHER ACUTE CARE HOSPITAL, "RIVERSIDE". ONE PATIENT EXPIRED, ONE IN CRITICAL CONDITION, PRELIMINARY DIAGNOSIS: BACTERIAL MENINGITIS. FACILITY NOTIFIED: DEPARTMENT OF HEALTH, AND CDC. ALL PRODUCT AT FACILITY QUARANTINED, DIRECTION FROM CDC IS TO DO NOTHING AT THIS TIME WITH THE B. BRAUN PRODUCT PER REPORTER. PT WHO DIED WAS ON NO OTHER CONCOMITANT MEDICATIONS, THE PT IN CRITICAL CONDITION RECEIVED OXYTOCIN. ADDITIONAL INFORMATION WAS PROVIDED BY THE FACILITY'S RISK MANAGER FIVE DAYS LATER, 9:20AM EST. IT WAS COMMUNICATED THAT THE SECOND PATIENT IS RECOVERING AND THE FACILITY IS PLANNING TO MOVE HER TO A REGULAR FLOOR. THE RISK MANAGER FURTHER REPORTED THE FOLLOWING: THE REPORTED LOT NUMBER 61038549 WAS DEFINITELY THE LOT USED ON THE PATIENT WHO EXPIRED. THE LOT NUMBER ON THE SECOND PATIENT WAS IDENTIFIED AS ONE OF THE FOLLOWING POTENTIAL LOTS: 61018945, 61034767, AND 61033656. THIS WAS DETERMINED AFTER THE FACILITY WENT THROUGH THE TRASH DUMPSTER AND DID NOT FIND ANY MORE KITS IDENTIFYING LOT NUMBER 61038549. THE FENTANYL AND DUROMORPH ARE DRAWN FROM VIALS BY THE CLINICIAN DURING THE PROCEDURE AND ARE NOT ADMIXED. REPORTER INDICATED THAT SHE DID NOT KNOW IF THE FENTANYL AND DUROMORPH CAME FROM THE B. BRAUN TRAY. SHE WAS INFORMED THAT B. BRAUN DOES NOT SUPPLY THESE DRUGS IN OUR TRAYS. THE DRUGS SUPPLIED IN OUR TRAYS ARE ONLY LIDOCAINE AND EPINEPHRINE. WHEN ASKED IF THERE WERE ANY PATIENT COMMONALITIES (I.E. CLINICIAN, LOCATION, HISTORY), IT WAS INDICATED NO. IT WAS REPORTED THERE WERE DIFFERENT PHYSICIANS, LOCATIONS, AND NO COMMON PATIENT HISTORY OR UNDERLYING DISEASES. BOTH PATIENTS WERE LABOR AND DELIVERY PATIENTS. WHEN ASKED IF THE BACTERIA CAUSING THE INFECTION WAS IDENTIFIED, IT WAS INDICATED THAT IT WAS, BUT SHE WAS UNWILLING TO SHARE THE INFORMATION, INDICATING SHE IS WORKING WITH THE CDC AND DOES NOT WANT TO COMMUNICATE THIS INFORMATION AT THIS TIME. THE CDC HAS ASKED THE FACILITY TO PULL THE B. BRAUN TRAYS, BUT TO NOT DO ANYTHING WITH THEM YET. IT WAS ALSO REPORTED THE SKIN WAS DISINFECTED USING STANDARD PROCEDURES WITH THE POVIDONE IODINE SUPPLIED IN THE B. BRAUN KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINOCAN SPINAL NEEDLE TRAY CAZ B. BRAUN MEDICAL, INC. NA 61038549

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R