BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3111566 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07625
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, MODEL # 8637-20, SN (B)(4), FOUND NO SIGNIFICANT ANOMALIES. THE END OF SERVICE (EOS) WAS DUE TO TIME PROGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO ICU WITH WITHDRAWAL SYMPTOMS AND WAS IMPROVING/DOING WELL WITH ORAL BACLOFEN AND VALIUM. TROUBLESHOOTING OF THE CATHETER WAS DONE VIA X-RAY AND IT LOOKS FINE, NOTHING OBVIOUS WAS NOTED. IT WAS REPORTED THAT IT SEEMS LIKE SOMETHING IS GOING ON WITH THE PUMP, QUESTIONING PUMP FAILURE. THE PATIENT WAS LAST REFILLED ON (B)(6), AND ALARM DATE IS (B)(6). ESTIMATED ERI WAS 17 MONTHS AS OF (B)(6). THE PUMP WAS USED TO DELIVER GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THE PATIENT WAS ADMITTED FOR ACUTE RESPIRATORY FAILURE REQUIRING MECHANICAL VENTILATION. THE PATIENT WAS FOUND TO HAVE TRACHEITIS AND EVENTUALLY WAS DISCHARGED HOME (B)(6) 2013 ON ANTIBIOTICS AND HOME OXYGEN. THE PATIENT WAS IN HER USUAL STATE OF HEALTH AT HOME ON OXYGEN THERAPY UNTIL APPROXIMATELY 18 DAYS LATER WHEN THE MOM STATED THAT THE PATIENT HAD A SORE THROAT AND BELIEVED HAD STREP THROAT. THE PATIENT¿S MOM HAD THE HCP CALL ANTIBIOTICS BUT THE PATIENT WAS NOT SEEN OR CHECKED FOR ¿GAS¿. THE PATIENT WAS TAKING AMOXICILLIN. THE PATIENT HAD INTERMITTENT FEVERS. ON (B)(6) THE PATIENT RETURNED TO ED (EMERGENCY DEPARTMENT) HAVING INCREASED RESPIRATORY DISTRESS AND PAIN. THE PATIENT¿S MOTHER BROUGHT THE PATIENT IN BECAUSE SHE WAS CONCERNED ABOUT HER BREATHING AND WAS ¿SURE HER GAS WAS ABNORMAL¿. THERE THE PATIENT¿S BLOOD GASSES SHOWED SIGNIFICANT HYPERCARBIA AND ACIDOSIS CO2 OF 187 NOT RESPONSIVE TO BIPAP IN ER. THE PATIENT WAS ADMITTED TO PICU AND EVENTUALLY HAD A TRACHEOSTOMY PLACEMENT ON (B)(6) 2013 AND WAS FOUND TO HAVE VENTILATOR DEPENDENCE. THE PATIENT DID DEVELOP AN INFECTION AT THE TRACHEOSTOMY SITE WHICH RESPONDED TO SEPTRA AND TOPICAL ANTIMICROBIALS. CULTURE FROM THE TRACH SITE SHOWED (B)(6). FAMILY TEACHING WAS DONE REGARDING TRACHEOSTOMY AND VENTILATOR CARE FOR DISCHARGE HOME. THE PATIENT WAS DISCHARGED HOME IN GOOD CLINICAL CONDITION (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213063 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Hospitalization