BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE FOR FRES 2008;GAMBRO-A

    MDR report key: 282456 · Received June 19, 2000

    Report

    Report Number
    8030665-2000-00196
    Event Type
    Injury
    Date Received
    June 19, 2000
    Date of Event
    May 22, 2000
    Report Date
    May 26, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REP REPORTS A PT CONNECTOR DISCONNECTED AT THE FACILITY. THE EVENT RESULTED IN A 300-400CC BLOODLOSS. NO ADDITIONAL INFO IS AVAILABLE. CLINICAL QUALITY MANAGER (CQM) IS OBTAINING MORE INFO REGARDING THIS EVENT. QUESTIONNAIRE FAXED TO DEPT OF NURSING ON 6/6/2000. 6/15/2000: NEW INFO RECEIVED FROM CONTINUOUS QUALITY MANAGEMENT. THIS PT EVENT WAS A LEAK AT THE PT CONNECTOR TO QUNINTON PERMCATH, AS THE CONNECTION WAS FOUND TO BE "LOOSE" AND NOT COMPLETELY DISCONNECTED. ESTIMATED BLOOD LOSS REPORTED AS 300CC. THE CONNECTION WAS TIGHTENED AND DIALYSIS TREATMENT WAS CONTINUED WITHOUT ANY FURTHER PROBLEMS. THERE WAS MEDICAL INTERVENTION AS A TRANSFUSION WAS ORDERED FOR THE NEXT DIALYSIS AS THE PT'S HEMOGLOBIN "WAS ALREADY LOW" (VALUE NOT REPORTED). 6/15/2000: "QS" LEFT TELEPHONE MESSAGE FOR D.O.N. REQUESTING AVAILABILITY OF COMPLAINT SAMPLE. 6/16/2000: "QS" CALLED CLINIC. CHIEF TECH REPORTED THE CORRECT BLOODLINE CATALOG NUMBER AND THAT THE LOT NUMBER AND COMPLAINT SAMPLE ARE NOT AVAILABLE. STATES THE BLOODLINE WAS NOT SAVED, AS THE CAUSE OF THE LEAK WAS DUE TO USER ERROR (OR PROCEDURAL CLINICAL VARIANCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRES 2008;GAMBRO-A BLOODLINE TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R FRESENIUS 2008H.