BEUDAMED
    FDA Adverse Event Death Summary report: N

    L-CATH PERIPHERALLY INSERTED VENOUS CATH

    MDR report key: 99631 · Received June 19, 1997

    Report

    Report Number
    99631
    Event Type
    Death
    Date Received
    June 19, 1997
    Date of Event
    May 8, 1997
    Report Date
    June 13, 1997
    Manufacturer
    LUTHER MEDICAL PRODUCTS
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMALE INFANT BORN ON 4/12/97 WEIGHING 810 GRAMS, 27 WEEKS GESTATION TRANSFERRED TO NEONATAL ICU. ON 4/26/97 A PICC CATHETER WAS INSERTED. ON 5/8/97 BABY WAS NOTED TO HAVE ACUTE CLINICAL DETERIORATION. BABY CODED, CPR INITIATED, RESUSCITATION EFFORTS WERE UNSUCCESSFUL. AUTOPSY PERFORMED ON 5/12/97. AT THIS POINT IN TIME AFTER THE REVIEW OF THE AUTOPSY REPORT, HOSP FEELS THAT THEY STILL CANNOT DETERMINE WHETHER THE DEATH WAS SPECIFICALLY RELATED TO THE DEVICE AS THE AUTOPSY REPORT ALSO IDENTIFIES ORGANISMS CONSISTENT WITH MALASSEZIA FURFUR IN EPICARDIAUM AS NOTED ON AUTOPSY REPORT. 26-DAY-OLD, EX-PREMATURE (27 WEEKS GESTATION) 1040GM FEMALE INFANT. NO OVERT DEVELOPMENTAL ANOMALIES. CENTRAL NERVOUS SYSTEM: MILD HYDROCEPHALUS. CARDIOVASCULAR SYSTEM: PERICARDIAL EFFUSION. CATHETER PERFORATION OF RIGHT ATRIUM. FOCAL RIGHT ATRIAL MYOCARDIAL NECROSIS. ORGANISMS CONSISTENT WITH MALASSEZIA FURFUR IN EPICARDIUM. RESPIRATORY SYSTEM: PARENCHYMAL HEMORRHAGE. IMMATURITY. GASTROINTESTINAL TRACT: HEPATIC EXTRAMEDULLARY HEMATOPOIESIS. NO PATHOLOGIC DIAGNOSIS. HEMATOPOIETIC SYSTEM: NO PATHOLOGIC DIAGNOSIS. URINARY TRACT: NO PATHOLOGIC DIAGNOSIS. FEMALE GENITAL SYSTEM: PARAMETRIAL ADRENAL REST. NO PATHOLOGIC DIAGNOSIS. ENDOCRINE SYSTEM: NO PATHOLOGIC DIAGNOSIS. MUSCULOSKELETAL SYSTEM: NO PATHOLOGIC DIAGNOSIS. PLACENTA: CHRONIC PLATE INFLAMMATION. CHORIONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PERIPHERALLY INSERTED VENOUS CATH PICC CATH DQO LUTHER MEDICAL PRODUCTS 28 GAUGE 1.2 FR 20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DAY Death