BEUDAMED
    FDA Adverse Event Death Summary report: N

    OHMEDA BILIBLANKET PHOTOTHERAPY SYSTEM

    MDR report key: 165489 · Received May 5, 1998

    Report

    Report Number
    1121732-1998-00002
    Event Type
    Death
    Date Received
    May 5, 1998
    Date of Event
    April 11, 1998
    Manufacturer
    OHMEDA
    Product Code
    LBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE BRAND NAME OF THE PRODUCT AS LISTED IN SECTION D1. THE ORIGINAL MEDWATCH REPORT, WHICH WAS FAXED TO FDA ON 05/12/1998, LISTED THE UNIT AS A BILIBLANKET PHOTOTHERAPY SYSTEM. THIS SUPPLEMENTAL REPORT CORRECTS THE BRAND NAME TO BILIBLANKET PLUS PHOTOTHERAPY SYSTEM. OHMEDA IS ALSO SUBMITTING A BASELINE REPORT FOR THIS PRODUCT. THE OFFICE OF THE MEDICAL EXAMINER OF COOK COUNTY HAS DETERMINED THAT A 4-DAY-OLD PREMATURE INFANT BORN, DIED OF MASSIVE BLEEDING INTO THE VENTRICLES OF THE BRAIN DUE TO PREMATURITY. THE MANNER OF DEATH WAS NATURAL. A SKIN CONDITION THAT DEVELOPED DURING HIS HOSPITALIZATION WAS DUE TO PROTOPORPHYRIA, A GENETICALLY INHERITED CONDITION & DID NOT CONTRIBUTE TO DEATH. INFANT WAS BORN AT 8:27 P.M. ON APRIL 10, 1998, WITH A BIRTH WEIGHT OF 1.3 POUNDS (611 GRAMS) & AN ESTIMATED GESTATIONAL AGE OF 23-24 WEEKS. AT BIRTH, THE INFANT HAD DIFFICULTY BREATHING, ELEVATED BLOOD ACID CONCENTRATIONS, LOW BLOOD PRESSURE, & SUSPICION OF BACTERIA IN THE BLOOD STREAM. INTERVENTRICULAR BLEEDING OCCURS IN 35 TO 45% OF NEWBORNS LESS THAN 35 WEEKS GESTATION. SEVENTEEN HOURS AFTER BIRTH, INFANT WAS STARTED ON PHOTOTHERAPY WITH A FIBEROPTIC BLANKET FOR ELEVATED BLOOD BILIRUBIN, A BREAKDOWN PRODUCT OF RED BLOOD CELLS. THREE HOURS LATER, NURSES NOTED THAT THE INFANT'S BACK & BUTTOCKS WERE BECOMING RED & DISCONTINUED TREATMENT WITH THE FIBEROPTIC BLANKET. THE SKIN LESIONS PROGRESSED TO BLISTERING & SLOUGHING OF THE TOP LAYER OF SKIN, THE EPIDERMIS. THE OFFICE OF THE MEDICAL EXAMINER HAS DETERMINED THAT THE CAUSE OF THE SKIN CONDITION WAS A CUTANEOUS PHOTOSENSITIVITY REACTION DUE TO PROTOPORPHYRIA. THE POSTMORTEM BLOOD PROTOPORPHRIN WAS 178 MICROGRAMS/DECILITER. ON THE BASIS OF A PRESUMED HEMATOCRIT OF 40%, THE PROTOPORPHYRIN CONCENTRATION IN THE PACKED RED BLOOD CELLS WOULD HAVE BEEN 445 MICROGRAMS/DECILITER, A VALUE CONSISTENT WITH PROTOPORPHYRIA. THE NORMAL LEVEL IN PACKED RED BLOOD CELLS IS LESS THAN 60 MICROGRAMS/DECILITER. THE OFFICE OF THE MEDICAL EXAMINER FOUND NO EVIDENCE THAT INFANT SUFFERED THERMAL BURNS. CONSULTING ENGINEERS WHO EXAMINED THE FIBEROPTIC BLANKET FOUND THAT IT PERFORMED ACCORDING TO THE MFR'S SPECS. PROTOPORPHYRIA RESULTS FROM A GENETIC DEFICIENCY OF THE ENZYME FERROCHELATAGE THAT RESULTS IN AN OVERPRODUCTION OF PROTOPORPHRIN. PHOTOSENSITIVITY IS A UNIVERSAL FEATURE OF THIS DISEASE & PRESENTS IN INFANCY. REDNESS & DIFFUSE FLUID ACCUMULATION IN THE SKIN ARE COMMON MANIFESTATIONS. VESICLES, BLISTERING, & ALTERED SKIN FRAGILITY ARE SEEN LESS FREQUENTLY. THE DAMAGE TO THE SKIN RESULTS FROM LIGHT ACTIVATION OF PROTOPORPHYRIN IN THE BLOOD VESSELS OF THE SKIN THAT DISSOLVES CELL MEMBRANES. PROTOPORHYRIA IS ALSO ASSOCIATED WITH LIVER DISEASE OF VARYING SEVERITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 611 GM., 23 WEEK GESTATIONAL AGE, BABY WAS PLACED ON THE BILIBLANKET WITHIN 12 HOURS OF BIRTH, ALTHOUGH THERE WAS NO PRETREATMENT DOCUMENTATION OF BILIRUBIN LEVELS PRIOR TO INITIATION OF TREATMENT. AFTER BABY HAD BEEN ON BILIBLANKET FOR APPROX. 5 HOURS, A CLINICIAN ALLEGEDLY OBSERVED WHAT WAS DESCRIBED AS "A BURN" ON THE INFANT'S BACK. THE PT HAD MULTIPLE MEDICAL PROBLEMS AND WAS INTUBATED WHILE ALSO BEING TREATED ON A VENTILATOR AND IN AN INCUBATOR. THE BILIBLANKET WAS REMOVED FROM THE PT AND THE PT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ON 4/14/1998 THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA BILIBLANKET PHOTOTHERAPY SYSTEM NEONATAL PHOTOTHERAPY UNIT LBI OHMEDA BILIBLANKET 1.5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INCUBATOR, VENTILATOR, 4/10 - 4/14/1998.