BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 284711 · Received June 27, 2000

    Report

    Report Number
    8030665-2000-00214
    Event Type
    Malfunction
    Date Received
    June 27, 2000
    Date of Event
    May 16, 2000
    Report Date
    June 14, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRACK IN VENOUS MEDICATION PORT REPORTED DURING TREATMENT. SAMPLE WAS SENT DIRECTLY TO CORPORATE AND WILL BE FORWARDED. FOLLOW-UP WITH CUSTOMER REQUIRED. CALLED CUSTOMER ON 6-6-00 AND ASKED CUSTOMER NOT TO SEND SAMPLE TO CORPORATE. ADDITIONALLY CUSTOMER NOT AVAILABLE. FAXED QUESTIONNAIRE FOR ADD'L INFO ON 6-6-00. RECEIVED QUESTIONNAIRE ON 6-7-00. EVENT OCCURRED 1 HOUR INTO TREATMENT. BLOOD LOSS WAS MINIMAL, <10CC. NO ALARM CONDITION WAS PRESENT. THE BLOOD FLOW RATE AT TIME OF THE EVENT WAS 300ML/MIN AND THE "VP" WAS 180 PRE-INCIDENT AND 160 POST-INCIDENT. NO PT ILL EFFECTS. 6/14/00 FACILITY CALLED UPON RECEIPT OF PRODUCT COMPLAINT. QS CALLED FACILITY AND OBTAINED FURTHER INFO FROM HCP. THE PT WAS UNDERGOING DIALYSIS. DRIPPING WAS SEEN COMING FROM THE INJECTION SITE, APPROXIMATELY 5-10CC BLOOD; HOWEVER, THE VENOUS BLOOD LINE HAD TO BE CHANGED IN ORDER TO CONTINUE THE TREATMENT, EBL 75CC TOTAL. THERE WERE NO ADVERSE EFFECTS TO THE PT AS A RESULT OF THIS BLOOD LOSS. MDR FILED DUE TO THIS BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE TUBINT FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA 9PR057

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 2008H