BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINIMACS

    MDR report key: 4119133 · Received September 22, 2014

    Report

    Report Number
    MW5038339
    Event Type
    Death
    Date Received
    September 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MILTENYI BIOTEC
    Product Code
    KSR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) IS A (B)(6) BOY WHO WAS DIAGNOSED AS HAVING SEVERE COMBINE IMMUNE DEFICIENCY ON NEWBORN SCREENING. HE UNDERWENT AN UNRELATED BONE MARROW TRANSPLANT ON (B)(6) 2014. HIS COURSE HAS BEEN COMPLICATED BY TOXICITY AND INFECTION. HE WAS ADMITTED TO THE PICU ON THREE SEPARATE OCCASIONS; FIRSTLY ON (B)(6) 2014 FOR FLUID OVERLOAD AND WAS TRANSFERRED BACK TO THE BMTU ON (B)(6) 2014; SECONDLY ON (B)(6) 2014 FOR SEVERE VOD AND RETURNED TO BMTU ON (B)(6) 2014; AND LASTLY ON (B)(6) 2014 AND STAYED UNTIL THE TIME OF HIS DEATH. HIS INFECTIOUS COMPLICATIONS WERE: DISSEMINATED CMV PRE AND POST TRANSPLANT; DISSEMINATED EBV POST-TRANSPLANT; PULMONARY ASPERGILLOSIS; PJP PNEUMONIA (BASED ON CLINICAL SYMPTOMS); PRESUMED SEPSIS CULTURE NEGATIVE (ABDOMINAL PAIN, TACHYCARDIA, HYPOTENSION). HIS TOXICITIES WERE RESPIRATORY FAILURE; SEVERE VOD; PULMONARY HEMORRHAGE; OSTEOPENIA WITH MULTIPLE SMALL BONE FRACTURES; PANCREATITIS; RENAL INSUFFICIENCY REQUIRING PERITONEAL DIALYSIS; ARDS; HYPERTRIGLYCERIDEMIA. ALL MEDICALLY APPROPRIATE INTENSIVE CARE WAS PROVIDED IN ORDER TO SUSTAIN HIM. HOWEVER, IT HAD BECOME MORE DIFFICULT TO MAINTAIN HIS OXYGENATION DESPITE THE USE OF OSCILLATOR VENTILATOR AND NITRIC OXIDE. ON (B)(6) 2014 HE WAS MADE AND (ALLOWED NATURAL DEATH) BY HIS PARENTS AND THE PICU ATTENDING AT 0200 AND HE SUCCUMBED AT 0955.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587548 CLINIMACS CLINIMACS SYSTEM KSR MILTENYI BIOTEC CLINIMACS PLUS INSTRUMENT 6131007010/D0481/B2010

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Death SULFAMETHOXAZOLE-TRIMETHOPRIM 45 MG IV Q 6 HOURS| URSODIOL 75 MG BID| CHOLECALCIFEROL 1000 UNITS Q DAY| RITUXIMAB 150 MG IV Q 7 DAYS X 4 DOSES| MEROPENEM 400 MG IV Q 8 HOURS| CHLOROTHIAZIDE 8 MG IV Q 12 HOURS| EPOTIN ALFA 3500 UNITS Q M-W-F IV| GANCICLOVIR 50 MG IV Q 12 HOURS| CLONIDINE 0.2 MG TRANSDERMAL PATCH| VORICONAZOLE 150 MG IV Q 12 HOURS| VANCOMYCIN 150 MG IV Q 18 HOURS| AMPHOTERICIN B LIPOSOMAL 50 MG VI Q DAY| METHYLPREDNISOLONE 5 MG Q 6 HOURS| MICAFUNGIN 50 MG IV Q DAY| IMMUNE GLOBULIN INFUSION IV 3 GRAMS| LORAZEPAM 0.25 MG Q 8 HOURS