BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP SET

    MDR report key: 10320592 · Received July 24, 2020

    Report

    Report Number
    2243072-2020-01141
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 3, 2020
    Report Date
    August 31, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE THE ACTUAL PRODUCT WAS NOT RETURNED, AN INDIVIDUAL DETAILED INVESTIGATION COULD NOT BE PERFORMED, BUT IT IS SPECULATED THAT THIS EVENT OCCURRED DUE TO THE FOLLOWING PHENOMENON DESCRIBED IN THE PACKAGE INSERT OF THE ADMINISTERED PACLITAXEL. "WHEN ADMINISTERING THIS DRUG USING AN INFUSION PUMP, USING AN INFUSION SET WITH A FILTER NETWORK (A FILTER WITH A SMALL AREA) BUILT INTO THE TUBE MAY CAUSE CRYSTALS OF PACLITAXEL, WHICH RARELY PRECIPITATE DUE TO PHYSICAL STIMULATION OF THE PUMP, TO OCCUR. DO NOT USE AN INFUSION SET THAT INCORPORATES A FILTER SCREEN, AS THIS MAY CLOG THE FILTER SCREEN AND CAUSE THE PUMP TO STOP." A DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SP SET WAS CLOGGED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN (B)(6), THE PUMP ALARM SOUNDED DURING ADMINISTRATION USING AN INFUSION SET CONSISTING OF A SPIKE SET, AN IV LINE CONNECTION KIT, AND A NIPRO¿S INFUSION SET WITH FILTER TO A CV PATIENT IN THE OBSTETRICS AND GYNECOLOGY WARD, AND THE WARD NURSE CONFIRMED A REDUCTION IN THE FLOW RATE. THE PATIENT WAS RECEIVING AP THERAPY. THE INCIDENT OCCURRED DURING ADMINISTRATION OF PACLITAXEL, AND THE NURSE FOUND THAT THE INSIDE OF THE TUBING WAS BECOMING WHITE-TURBID. IT IS INFERRED THAT PACLITAXEL WAS AFFECTED BY SOMETHING AND PRECIPITATION OF PACLITAXEL OCCURRED, LEADING TO CLOG OF THE FILTER. THERE WERE 3 CASES OF THE SAME INCIDENT OCCURRING ONLY IN THIS WARD IN (B)(6) 2020. THIS HAD NEVER OCCURRED BEFORE. MAJOR CHANGES MADE AROUND JUNE ARE ONLY INTRODUCTION OF THE SPIKE SET AND IV LINE CONNECTION KIT, WITH NO CHANGE IN DRUGS OR NO POSSIBILITY THAT DRUGS LISTED UNDER PROHIBITED CONCOMITANT USE WERE USED. NIPRO¿S IV SET HAS BEEN USED CONVENTIONALLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SP SET WAS CLOGGED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN (B)(6), THE PUMP ALARM SOUNDED DURING ADMINISTRATION USING AN INFUSION SET CONSISTING OF A SPIKE SET, AN IV LINE CONNECTION KIT, AND A NIPRO¿S INFUSION SET WITH FILTER TO A CV PATIENT IN THE OBSTETRICS AND GYNECOLOGY WARD, AND THE WARD NURSE CONFIRMED A REDUCTION IN THE FLOW RATE. THE PATIENT WAS RECEIVING AP THERAPY. THE INCIDENT OCCURRED DURING ADMINISTRATION OF PACLITAXEL, AND THE NURSE FOUND THAT THE INSIDE OF THE TUBING WAS BECOMING WHITE-TURBID. IT IS INFERRED THAT PACLITAXEL WAS AFFECTED BY SOMETHING AND PRECIPITATION OF PACLITAXEL OCCURRED, LEADING TO CLOG OF THE FILTER. THERE WERE 3 CASES OF THE SAME INCIDENT OCCURRING ONLY IN THIS WARD IN (B)(6) 2020. THIS HAD NEVER OCCURRED BEFORE. MAJOR CHANGES MADE AROUND (B)(6) ARE ONLY INTRODUCTION OF THE SPIKE SET AND IV LINE CONNECTION KIT, WITH NO CHANGE IN DRUGS OR NO POSSIBILITY THAT DRUGS LISTED UNDER PROHIBITED CONCOMITANT USE WERE USED. NIPRO¿S IV SET HAS BEEN USED CONVENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783383 SP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other