BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYHSURGPN,400X2D,PBI-AM,-,OQI,5

    MDR report key: 6559510 · Received May 11, 2017

    Report

    Report Number
    2026095-2017-00085
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 2, 2017
    Report Date
    May 25, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651136238
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202415064, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 06-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). 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

    ALL INFORMATION REASONABLY KNOWN AS OF 25-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

    THE PUMP WAS RETURNED WITH TWO SILVER-SOAKER CATHETERS. THE PUMP WAS REFILLED WITH 0.9% OF SALINE USING THE REPEATER PUMP TO THE NOMINAL VALUE OF 400ML. INFUSION WAS VERIFIED AND THE FLOW ACCURACY TEST WAS PERFORMED. AFTER 75 HOURS OF TESTING, DUAL LINE #1 YIELDED A FLOW RATE OF 1.82ML/HR AND DUAL LINE #2 YIELDED A FLOW RATE OF 1.82ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. A PRESSURE POT TEST WAS PERFORMED FOR THIS SAMPLE ON THE FLOW RESTRICTORS. THE TUBING WAS DETACHED FROM THE PUMP AND CONNECTED TO A PRESSURE GAUGE. THE AVERAGE BLADDER PRESSURE USED WAS 8.16PSI. THE FLOW RESTRICTOR DUAL LINE 1 YIELDED A FLOW RATE OF 2.06ML/HR WHICH IS WITHIN THE SPECIFICATION WITH A 15% TOLERANCE. THE FLOW RESTRICTOR DUAL LINE 2 YIELDED A FLOW RATE OF 2.06ML/HR WHICH IS WITHIN THE SPECIFICATION WITH A 15% TOLERANCE. THE COMBINED FLOW RATE IS 4.12ML/HR WHICH IS WITHIN SPECIFICATIONS. THE INVESTIGATION SUMMARY CONCLUDED THAT A FAST FLOW EVENT WAS NOT OBSERVED FOR PUMP #1. DURING THE FLOW ACCURACY TEST, THE PUMP WAS WITHIN SPECIFICATIONS. DURING PRESSURE POT TESTING, THE FLOW RESTRICTOR MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. ALL INFORMATION REASONABLY KNOWN AS OF 22-JUN-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00084 FOR THE FIRST EVENT. FILL VOLUME: 400; FLOW RATE: 4ML/HR (2+2ML/HR); PROCEDURE: LAPAROTOMY FOR SMALL BOWEL RESECTION. CATHPLACE: PRE-PERITONEAL SPACE. A REPORT WAS RECEIVED FROM THE UNITED KINGDOM STATING THE PAIN BUSTER COMPLETED EARLIER THAN EXPECTED. THE INFUSION WAS EXPECTED TO LAST AROUND 5-DAYS BUT WAS ACTUALLY COMPLETED IN 3-DAYS. THE CATHETER WAS REMOVED UNEVENTFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 28-APR-2017 STATED PAIN NURSE PRACTITIONER PROVIDED CLARIFICATION STATING THE INITIAL REPORT OF THE EVENT SYSTEM BEING COMPLETED EARLY WAS INITIALLY STATED (B)(6) 2017, PRIOR TO REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341663 HYHSURGPN,400X2D,PBI-AM,-,OQI,5 CATHETERS MEB HALYARD - IRVINE PS12508-A 0202415064 30680651136238

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR