BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGPN,600X2-14,CB SAF,-,OQ,5

    MDR report key: 6419169 · Received March 20, 2017

    Report

    Report Number
    2026095-2017-00046
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    February 16, 2017
    Report Date
    May 16, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134760
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 09-JUN-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 15-MAY-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO INFORMATION PROVIDED REGARDING THE RETURN OF THE ACTUAL COMPLAINT PRODUCT TO THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED PROVIDED ADDITIONAL SYMPTOMS EXPERIENCED BY THE PATIENT DURING THE EMERGENCY ROOM ADMISSION; NAUSEA, VOMITING, DROWSINESS, AND DIZZINESS.

    Description of Event or Problem · 1

    FILL VOLUME: 700 ML, FLOW RATE: 6 ML/HR, PROCEDURE: ROTATOR CUFF REPAIR, CATHPLACE: NECK, DATE OF PROCEDURE: (B)(6) 2017. IT WAS REPORTED A PATIENT HAD SURGERY ON (B)(6) 2017, AND POST-SURGERY, THE PATIENT WOKE UP TO FEEL HER THROAT IN PAIN IN CONJUNCTION WITH DIFFICULTY BREATHING. THE HOSPITAL STAFF ADVISED THAT THIS WAS PART OF THE RECOVERY AND THE ISSUE WOULD RESOLVE IN TIME. THE PATIENT WAS DISCHARGED WITH THE ELASTOMERIC INFUSION PUMP, AND THE NEXT MORNING, HER FACE AND BODY WAS COVERED IN HIVES. SHE ALSO EXPERIENCED A SHORTNESS OF BREATH. THE PATIENT'S HUSBAND TOOK HER TO THE EMERGENCY ROOM (ER), AND WHILE EN-ROUTE TO THE ER, SHE TRIED TO ADJUST THE SELECT-A-FLOW (SAF) DIAL TO 0, BUT THE DIAL BROKE. THE PUMP WAS CLAMP UPON ARRIVING TO THE ER, AND SYMPTOMS BEGAN TO IMPROVE TWO HOURS AFTER CLAMPING. THE ER STAFF ADVISED THAT SHE WAS EXPERIENCING AN ALLERGIC REACTION, WHICH COULD POSSIBLY BE FROM THE MEDICATION IN THE ELASTOMERIC INFUSION PUMP. AS A RESULT, SHE RECEIVED ANTIHISTAMINES (BENADRYL), AND FLUID THERAPY TO FLUSH HER SYSTEM OUT. THE PUMP WAS NOT LABELLED WITH TYPE OF MEDICATION IT CONTAINED. ADDITIONAL INFORMATION RECEIVED ON 16-MAR-2017 STATED THAT IT WAS BELIEVED THAT SHE HAD AN ALLERGIC REACTION TO EITHER THE ORAL PAIN MEDICATION OR THE ANTIBIOTICS SHE RECEIVED. ADDITIONAL INFORMATION RECEIVED ON 17-MAR-2017 STATED THAT THE ONLY MEDICATION THE PATIENT RECEIVED DURING INFUSION WAS MOTRIN 800 MG. IT WAS NOTED THAT THE PATIENT RECEIVED MOTRIN IN THE PAST AND EXPERIENCED NO ADVERSE REACTIONS TO IT. IT WAS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL MEDICATIONS PRE-OPERATIVELY OR INTRA-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201181 SURGPN,600X2-14,CB SAF,-,OQ,5 ELASTOMERIC - SAF MEB HALYARD - IRVINE CB6004 UNKNOWN 30680651134760

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R MOTRIN 800 MG