BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1946282 · Received January 4, 2011

    Report

    Report Number
    1423500-2011-00024
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 14, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS (MANIFESTED AS PERITONEAL CLOUDY EFFLUENT AND ABDOMINAL PAIN), FLANK PAIN AND FEELING UNWELL WHICH REQUIRED HOSPITALIZATION ((B)(6) 2010). ON (B)(6) 2010, NUTRINEAL PD4 1.1% WAS DISCONTINUED AND THE PERITONEAL DIALYSIS (PD) REGIMEN WAS SWITCHED TO PHYSIONEAL 40 (2X2.5L 1.36% AND 1X2.5L 2.27%) AND EXTRANEAL VIAFLEX THERAPIES. THE SAME DAY, THE PATIENT RECEIVED ANTIBIOTIC TREATMENT WITH GENTAMYCIN 8MG 4 TIMES/DAY IP, CEFUROXIM 500MG 4 TIMES/DAY IP, VANCOMYCIN 250MG 4 TIMES/DAY IP AND FORTUM 250MG 4 TIMES/DAY IP. ON (B)(6) 2010, GENTAMYCIN AND CEFUROXIM WERE DISCONTINUED. ON (B)(6) 2010, FORTUM WAS DISCONTINUED. %. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, THE PATIENT WAS RECOVERING FROM THE STERILE PERITONITIS, FLANK PAIN AND FEELING UNWELL. THE SAME DAY, VANCOMYCIN WAS DISCONTINUED. THE PHYSICIAN BELIEVED THE EVENTS OF STERILE PERITONITIS, FLANK PAIN AND FEELING UNWELL WERE RELATED TO NUTRINEAL PD4 THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2010 A (B)(4) FACILITY REPORTED A FLO GARD PUMP WHICH INFUSED UNKNOWN MEDICATION PROGRAMMED TO INFUSE IN 24 HOURS WHICH OVERINFUSED IN 2 HOURS INTO A (B)(6) OLD BOY IN THE INTENSIVE CARE UNIT (ICU) FOR AN UNKNOWN DIAGNOSIS. THE CHILD WAS REPORTEDLY IN STABLE CONDITION. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R SIMVASTATIN, DIOVAN (VALSARTAN), METOPROLOL,| MCP HEXAL (METOCLOPRAMIDE) VANCO-SAAR (VANCOMYCIN)| RENACET (MINERAL SUPPLEMENT), LACTULOSE AL,| ALLOPURINOL, BICANORM (SODIUM BICARBONATE),| SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE),| (CALCITRIOL), ELUTIT CALCIUM (CALCIUM), ARANESP| SALBUHEXAL (SALBUTAMOL, CALCITRIOL KYRAMED| AMLO CORAX (AMLODIPINE), MIMPARA| EXTRANEAL VIAFLEX AND NUTRINEAL PD4