BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL LINE BAX 550/1550 8MM POST/PLL

    MDR report key: 148694 · Received February 11, 1998

    Report

    Report Number
    8030665-1998-00628
    Event Type
    Injury
    Date Received
    February 11, 1998
    Date of Event
    January 24, 1998
    Report Date
    February 11, 1998
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PIR#9800188 SAMPLE NOT AVAILABLE FOR EVALUATION. WITHOUT A SAMPLE TO EVALUATE, THE COMPLAINT AS STATED, COULD NOT BE CONFIRMED. HOWEVER, A LOT NUMBER WAS PROVIDED AND THE MFG RECORDS WERE REVIEWED. THIS REVIEW SHOWED NO ISSUES WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. COMPLAINT CLOSED. QUALITY SYSTEMS WILL MONITOR THIS INFO IN FUTURE TRENDING. CUSTOMER LETTER SENT. **7/2/1998- NOTED INCORRECT INFO IN EVALUATION SUMMARY. CORRECTED INFO AND RESUBMITTED MEDWATCH FORM.

    Description of Event or Problem · 1

    RECEIVED COMPLAINT CONCERNING ABOVE PRODUCT FROM PRODUCT MANAGER. CHIEF TECHNICIAN REPORTS THAT THREE HOURS INTO THE TREATMENT THE BLOOD PUMP SEGMENT CAME APART AT THE OUTLET SIDE WHERE IT IS CONNECTED WITH THE MAIN LINE TUBING. HEALTHCARE PROFESSIONAL WAS AT THE MACHINE WHEN EVENT OCCURRED. PUMP WAS IMMEDIATELY STOPPED, HCP ATTEMPTED TO REINFUSE, BUT HAD TO STOP DUE TO AIR IN SYSTEM. ESTIMATED BLOOD LOSS OF 200ML FROM INITIAL LEAK AND LOSS OF EXTRACORPOREAL SYSTEM. THERE WAS NO FURTHER INJURY TO THE PT. LEFT FACILITY IN STABLE CONDITION. THE ACTUAL SAMPLE HAS BEEN DISCARDED. A RESPONSE LETTER HAS BEEN SENT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE BAX 550/1550 8MM POST/PLL BLOOD LINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA * RYN037

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other BAXTER 550 MACHINE, F8 DIALYZER.