BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGPN,270X5,HMPMPC,-,LFR-CS,24

    MDR report key: 5252101 · Received November 26, 2015

    Report

    Report Number
    2026095-2015-00328
    Event Type
    Injury
    Date Received
    November 26, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 30, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE ACTUAL DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND LABEL REVIEW WAS PERFORMED. RESULTS: AS A DEVICE ANALYSIS CANNOT DETERMINE THE ROOT CAUSE OF THE FLOW ISSUE, NO DEVICE TESTING METHODS ARE AVAILABLE. IN ADDITION, THE CUSTOMER INDICATED THAT THEY USE A BAXA FILLER TO FILL THE PUMPS. A PHARMACIST REPORTED THAT THE FILLER WOULD BE TESTED TO ENSURE THE CORRECT SALINE VOLUME IS CORRECT AND NOT UNDER FILLED. NO FURTHER INFORMATION HAS BEEN PROVIDED IN REGARDS TO THESE TEST RESULTS. THE PATIENTS IN THESE INCIDENTS EXPERIENCED ADVERSE SIGNS AND SYMPTOMS OF NAUSEA AND VOMITING AND ANOTHER PATIENT EXPERIENCED BLURRED VISION. BASED ON THE U.S. NATIONAL LIBRARY OF MEDICINE COMMON SIDE EFFECTS OF 5 FU ( FLUOROURACIL ) INCLUDE NAUSEA AND VOMITING. ACCORDING TO THE MASCC TEXTBOOK OF CANCER SUPPORTIVE CARE AND SURVIVORSHIP ALMOST ONE-THIRD OF PATIENTS GETTING DOSES OF 5 FU DEVELOP SOME TYPE OF OCULAR SIDE EFFECT MANIFESTED BY BLURRED VISION, PHOTOPHOBIA, EXCESS TEARING, AND EYE IRRITATION. THEREFORE , THE DRUG 5 FU MAY BE A CONTRIBUTOR TO THIS INCIDENT. CONCLUSION: AS THE DEVICE ANALYSIS CANNOT DETERMINE THE ROOT CAUSE OF THE FLOW ISSUE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE (IFU) THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE INCLUDING FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT REPORTING SYSTEMS FOR MONITORING, TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00329/15-01066(B). FILL VOLUME: 230ML, FLOW RATE: ASKU, PROCEDURE: ASKU, CATHPLACE: ASKU, INFUSION STARTED: (B)(6) 2015 AT 5:00PM, INFUSION ENDED: (B)(6) 2015 AT 3:30PM. IT WAS REPORTED BY THE PHARMACIST ON (B)(6) 2015 THAT AN INFUSION ENDED SOONER THAN EXPECTED. THE PATIENT WAS HOSPITALIZED FOR CONFUSION, NAUSEA AND VOMITING. THE PATIENT WAS EVALUATED AND DISCHARGED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782327 SURGPN,270X5,HMPMPC,-,LFR-CS,24 ELASTOMERIC PUMP MEB HALYARD - IRVINE C270050 0202101074

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization