BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYHSURGPN,400X2-14,CB SAF,-,OQ,5

    MDR report key: 6982966 · Received October 27, 2017

    Report

    Report Number
    2026095-2017-00185
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 30, 2017
    Report Date
    December 14, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134722
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ACTUAL DEVICE WAS RETURNED AND THE DEVICE EVALUATION IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE DEVICE WAS RECEIVED EMPTY. A VISUAL OBSERVATION FOUND A PARTIAL BREAK IN THE TUBING AT THE BLUE CONNECTOR. WHEN THE PUMP WAS RECEIVED THE PINCH CLAMP WAS ALL THE WAY UP AGAINST THE DISTAL SNAP CAP AND CLAMPED SHUT WHICH MAY HAVE CREATED ENOUGH TENSION ON THE TUBING TO CREATE THE BREAK. AN ATTEMPT WAS MADE TO REFILL THE PUMP WITH 30ML OF 0.9% SALINE USING A SYRINGE AND FLUID LEAKED FROM THE BREAK AT THE BLUE CONNECTOR. PRESSURE POT TESTING WAS PERFORMED ON THE SELECTED-A-FLOW UNIT FLOW RATES 2ML/HR, 4ML/HR, 8ML/HR AND 14ML/HR WITHOUT THE FILTER. THE SAF UNIT WAS DETACHED FROM THE PUMP. THE SAF UNIT WAS CONNECTED TO A PRESSURE GAUGE. THE AVERAGE BLADDER PRESSURE USED WAS 8.86PSI. THE SAF FLOW RATE 2ML/HR YIELDED A FLOW RATE OF 2.06ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-20% TOLERANCE. FLOW RATE 4ML/HR YIELDED A FLOW RATE OF 4.19ML/HR WHICH IS WITHIN SPECIFICATIONS WITH A +/- 20% TOLERANCE. FLOW RATE 8ML/HR YIELDED A FLOW RATE OF 7.90ML/HR WHICH IS BELOW SPECIFICATIONS WITH A +/- 20% TOLERANCE. FLOW RATE 14ML/HR YIELDED A FLOW RATE OF 13.93ML/HR WHICH IS BELOW SPECIFICATIONS WITH A +/- 20% TOLERANCE. DESTRUCTIVE ANALYSIS WAS PERFORMED USING A DREMEL TO CUT OPEN THE SAF. THE FLOW CONTROL TUBING WERE OBSERVED UNDER MAGNIFICATION. CRYSTALIZED MEDICATION WAS FOUND IN THE 1ML/HR FLOW CONTROL TUBING WHICH MOST LIKELY FORMED DURING FLOW ACCURACY TESTING. THE INVESTIGATION SUMMARY CONCLUDED THAT THE FAST FLOW WAS UNABLE TO BE EVALUATED. THE PUMP WAS RECEIVED EMPTY WITH A PARTIAL BREAK IN THE TUBING AT THE BLUE CONNECTOR. WHEN ATTEMPTING TO REFILL THE PUMP WITH SALINE FLUID LEAKED FROM THE BREAK. PRESSURE POT TESTING WAS PERFORMED AND ALL TESTED RATES WERE WITHIN SPECIFICATION WITH A 20% TOLERANCE. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS REPORTED TOP BE AVAILABLE BUT NO YET RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202671964, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 26-OCT-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).

    Description of Event or Problem · 1

    FILL VOLUME: 400 ML, FLOW RATE: 4 ML/HR, PROCEDURE: RIGHT ANKLE SURGERY, CATHPLACE: THIGH. IT WAS REPORTED THAT PATIENT HAD SURGERY RIGHT ANKLE SURGERY ON THURSDAY. ON FRIDAY THE PATIENT WOKE UP AND NOTICED THAT THE PUMP WAS TOTALLY FLAT. THE PATIENT COULD NOT GET IN CONTACT WITH ANYONE OVER THE WEEKEND AND SO SHE LEFT THE CATHETER IN PLACE. ON MONDAY THE PATIENT CALLED THE MANUFACTURER ASKING QUESTIONS, REPORTING THE COMPLAINT AND INQUIRING IF SOMEONE COULD COME REMOVE IT FOR HER. THE PATIENT WAS INSTRUCTED THAT IF SHE WAS INSTRUCTED TO REMOVE IT HERSELF THAN SHE COULD DO IT AND SHE WAS INSTRUCTED ON HOW TO DO THAT. THE PATIENT REPORTED BEING SCARED AND WAS ADVISED TO CALL THE SURGERY CENTER TO DISCUSS REMOVAL OPTIONS. THERE WERE NO REPORTED SIDE EFFECT FROM THE INFUSION. ADDITIONAL INFORMATION RECEIVED 05-OCT-2017 STATED THE PATIENT REMOVED THE CATHETER ON MONDAY. DURING THE PUMP'S INFUSION THE PATIENT DID NOT USE ANY WARMING DEVICES AND DID NOT APPLY ANY PRESSURE TO THE PUMP. WHEN THE PATIENT WAS LAYING IN BED, THE PUMP WAS RIGHT NEXT TO HER WAIST. THE PATIENT WAS UNSURE OF THE MEDICATION IN THE PUMP AND JUST KNEW IT WAS SOME TYPE OF NUMBING AGENT. THE PATIENT DID NOT HAVE ANY SIGNS AND SYMPTOMS OF DRUG TOXICITY. THE PUMP COMPLETED IN APPROXIMATELY 24-HOURS. ADDITIONAL INFORMATION RECEIVED 24-OCT-2017 STATED THE PATIENT'S SKIN ON HER WHOLE RIGHT LEG BROKE OUT AFTER THE PUMP WAS DISCONNECTED 1-2 DAY. ORAL ANTIBIOTICS MINOCYCLINE AND TOPICAL CLOBETASOL WAS PRESCRIBED FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763351 HYHSURGPN,400X2-14,CB SAF,-,OQ,5 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, MEB HALYARD - IRVINE CB004 0202671964 30680651134722

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention