BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,600X1-7D,CB SAF,-,OQ,5

    MDR report key: 5519788 · Received March 23, 2016

    Report

    Report Number
    2026095-2016-00019
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 6, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE DEVICE WAS RETURNED. THE ORIGINAL PACKAGING WAS NOT RETURNED WITH THE DEVICE. PRESSURE POT TESTING WAS PERFORMED ON THE FLOW CONTROL TUBING (SELECTED-A-FLOW UNIT) FLOW RATES 1ML/HR, 2ML/HR, 4ML/HR AND 7ML/HR. THE SAF UNITS WERE DETACHED FROM THE PUMP AND HOOKED ONTO A PRESSURE GAUGE. THE FILTER WAS ALSO REMOVED FROM THE TUBING FOR THIS TEST. THE AVERAGE BLADDER PRESSURE USED WAS 7.47PSI. FLOW RATE 1ML/HR YIELDED A FLOW RATE OF SAF #1 WAS 1.10ML/HR, WHICH IS WITHIN SPECIFICATION WITH A +/- 20% TOLERANCE. SAF #2 YIELDED A FLOW RATE OF 1.10ML/HR WHICH IS WITHIN SPECIFICATION WITH A +/- 20% TOLERANCE. FLOW RATE 2ML/HR FROM SAF #1 YIELDED A FLOW RATE OF 2.04ML/HR AND SAF #2 YIELDED A FLOW RATE OF 2.12, WHICH IS WITHIN SPECIFICATION WITH A +/- 20% TOLERANCE. FLOW RATE 4ML/HR YIELDED A FLOW RATE ON SAF #1 OF 3.95ML/HR AND SAF #2 YIELDED A FLOW RATE OF 3.99ML/HR WHICH IS WITHIN SPECIFICATION WITH A +/- 20% TOLERANCE. FLOW RATE 7ML/HR YIELDED A FLOW RATE ON SAF #1OF 7.31ML/HR AND ON SAF #2 OF 7.19ML/HR WHICH IS WITHIN SPECIFICATION WITH A +/- 20% TOLERANCE. THE INVESTIGATION SUMMARY CONCLUDES THAT DURING FLOW ACCURACY TEST, THE PUMP YIELDED A FLOW RATE THAT WAS WITHIN SPECIFICATIONS WITH A +/- 20% TOLERANCE. DURING PRESSURE POT TESTING FOR THE FLOW CONTROL TUBING (SAF UNIT) WITHOUT THE PUMP, THE FLOW RATES MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. NO FAST FLOW. 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)(4). METHOD: THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. THE DHR WAS REVIEWED FOR THE LOT NUMBER, OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. (B)(4) 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 (B)(4) COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    FILL VOLUME: 270 ML. FLOW RATE: 4 ML/HR. PROCEDURE: EXPLORATORY LAPAROTOMY. CATHPLACE: SURGICAL WOUND SITE. DATE/TIME INFUSION STARTED: (B)(6) 2016, 1130 AM. DATE/TIME INFUSION ENDED: (B)(6) 2016, 0700AM. A REPORT WAS RECEIVED STATING THE ELASTOMERIC PUMP INFUSED SOONER THAN EXPECTED. THE PAIN PUMP WAS PLACED BY ON (B)(6) 2016 AND THE PUMP WAS EMPTY BY THE MORNING OF (B)(6) 2016. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 06-MAR-2017 STATED THAT ON (B)(6) 2016, THE DEVICE INVOLVED IN THE INCIDENT WAS PUMPING MARCAINE INTO THE PATIENT'S BODY AND WAS REPORTED TO HAVE MALFUNCTIONED. AS A RESULT, THE PATIENT RECEIVED A 24-HOUR SUPPLY OF MARCAINE IN A 6-HOUR TO 8-HOUR TIME. WHILE THE DEVICE WAS MALFUNCTIONING, THE HOSPITAL STAFF WAS REPORTED TO HAVE INADEQUATELY MONITORED THE STATUS OF THE DEVICE AND THE INFUSION OF THE MARCAINE. IT WAS NOTED THAT THE PATIENT NOW SUFFERS SORENESS IN THE MUSCLES OF HIS ARMS, KNEES, LIMBS, AND HIS BODY AS A WHOLE. THE PATIENT WAS INFORMED AROUND FEBRUARY 2017 THAT THIS COULD CONSEQUENTLY OCCUR AS A RESULT OF THE OVERDOSE OF ANESTHESIA ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176519 SURGPN,600X1-7D,CB SAF,-,OQ,5 ELASTOMERIC - SAF MEB HALYARD - IRVINE CB6007 0202193985

    Patients

    Seq Age Sex Outcome Treatment
    1