BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERITONEAL CATHETER

    MDR report key: 10380723 · Received August 7, 2020

    Report

    Report Number
    3009211636-2020-00183
    Event Type
    Death
    Date Received
    August 7, 2020
    Date of Event
    May 14, 2016
    Report Date
    August 7, 2020
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EFFICACY AND OUTCOMES OF CONTINUOUS PERITONEAL DIALYSIS VERSUS DAILY INTERMITTENT HEMODIALYSIS IN PEDIATRIC ACUTE KIDNEY INJURY SOURCE: PEDIATRIC NEPHROLOGY VOLUME 31, PAGES 1681¿1689(2016) PUBLISHED: 14 MAY 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM OCT-2013 TO OCT-2015, TO CHECK THE EFFICACY AND SAFETY OF CONTINUOUS PERITONEAL DIALYSIS (CPD) AND DAILY INTERMITTENT HEMODIALYSIS (DHD) WAS COMPARED IN 136 CHILDREN AGED 1 MONTH TO 16 YEARS REQUIRING RENAL REPLACEMENT THERAPY (RRT) FOR AKI (ACUTE KIDNEY INJURY). SIXTY-SIX PATIENTS DIED WITHIN 30 DAYS OF THE INITIATION OF RRT. THE UNDERLYING CAUSE OF AKI WAS THE STRONGEST PREDICTOR OF MORTALITY. ALL DEATHS OCCURRED IN PATIENTS WITH AKI OF ¿PRE-RENAL¿ OR ¿UNKNOWN¿ ETIOLOGIES, WHEREAS ALL PATIENTS WITH AKI WITH RENAL OR POST-RENAL CAUSES SURVIVED. IN THE PATIENTS TREATED WITH CPD, FATALITIES WERE MOSTLY RELATED TO THE UNDERLYING ETIOLOGY OF AKI (POST-CARDIAC SURGERY WITH REFRACTORY HEART FAILURE (8 OUT OF 33), CEREBRAL ISCHEMIA (10 OUT OF 33), AND OVERWHELMING SEPSIS (15 OUT OF 33). FIVE OF THE 33 DEATHS OCCURRED AFTER PARTIAL RENAL RECOVERY AND DISCONTINUATION OF PD THERAPY. IN THE DHD GROUP, THE LEADING CAUSES OF DEATH WERE CARDIAC FAILURE AND/OR CARDIAC ARRHYTHMIA (10 OUT OF 33), SEPSIS (10 OUT OF 33), HYPOTENSIVE EPISODES (5 OUT OF 33), DIALYSIS DISEQUILIBRIUM SYNDROME (4 OUT OF 33), HYPONATREMIA (2 OUT OF 33), AND SUDDEN DEATH OF UNKNOWN ETIOLOGY (2 OUT OF 33). ARTICLE: EFFICACY AND OUTCOMES OF CONTINUOUS PERITONEAL DIALYSIS VERSUS DAILY INTERMITTENT HEMODIALYSIS IN PEDIATRIC ACUTE KIDNEY INJURY. AUTHOR: BISWANATH BASU, PUBLISHED: 14 MAY 2016 THE DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845056 PERITONEAL CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other