BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERNAN PRESET PUMP

    MDR report key: 9950651 · Received April 10, 2020

    Report

    Report Number
    1722214-2020-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 19, 2020
    Report Date
    August 27, 2020
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC.
    Product Code
    MEA
    PMA / PMN Number
    K162165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 IS ADDITIONAL INFORMATION. FU1 G4 SHOULD HAVE BEEN 27-MAY-2020. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2020 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE DEVICE WAS RETURNED. THE PUMP WAS RETURNED (WITHOUT BATTERIES) TO SUMMIT MEDICAL FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE PUMP AND NO CONTAMINATION, VISUAL DAMAGE, OR TAMPER EVIDENCE WAS FOUND. THE PUMP WAS ABLE TO BE PROGRAMMED NORMALLY. A RUN TEST WAS PERFORMED AND THE PUMP RAN NORMALLY. A TIMING TEST AND DOWNSTREAM OCCLUSION ALARM TEST WERE PERFORMED AND THE PUMP PASSED BOTH EVALUATIONS. BASED ON THE PUMP SETTINGS/HISTORY, IT APPEARS THE PUMP RAN THE COMPLETE 400 ML¿S PRESCRIBED. THERE WERE SIX REQUESTS FOR A BOLUS, BUT ONLY FIVE DELIVERED. THE REASON FOR THIS IS BECAUSE THE LOCKOUT TIME HAD NOT PASSED WHEN A REQUEST WAS MADE. THE DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS AND THE PUMP PASSED THE EVALUATION TESTS. NO ISSUES WERE FOUND WITH THE PUMP. ALL INFORMATION REASONABLY KNOWN AS OF 21-JUL-2020 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    CORRECTION: D1 THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, D526406 AND THE ASSOCIATED SERIAL NUMBER, 211936, 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 (B)(6) 2020 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2020 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 AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT ENACTS THE BOLUS, IT DOESN'T STOP; IT KEEPS FLOWING. "SHE HAS TO HIT THE PAUSE BUTTON ON THE UNIT TO STOP IT FROM FLOWING." FURTHERMORE, ¿SHE STATES SHE POWERED OFF THE UNIT, AND REMOVED THE BATTERIES, AND THE FIRST TIME SHE DID THIS, IT RESET AND THE BOLUS WORKED FINE. BUT, IT HAPPENED AGAIN." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 20-MAR-2020 STATED THE PATIENT CONTACTED THE PHYSICIAN AND IT WAS DECIDED THE PATIENT WOULD NOT USE THE BOLUS FEATURE ON THE PUMP. THE PATIENT IS DOING 'OKAY' AND DOES NOT HAVE ANY PAIN AND IS TAKING ACETAMINOPHEN AND IBUPROFEN FOR PAIN MANAGEMENT. THE PATIENT DENIED ANY INJURY OR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413563 KERNAN PRESET PUMP ELECTRONIC INFUSION PUMPS & SYSTEMS MEA SUMMIT MEDICAL PRODUCTS, INC. 220452 D526406

    Patients

    Seq Age Sex Outcome Treatment
    1 ACETAMINOPHEN| IBUPROFEN