BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 10192520 · Received June 24, 2020

    Report

    Report Number
    3015537318-2020-00001
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 24, 2020
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED IN THE INITIAL MDR REPORT, JOHNSON AND JOHNSON WAS RESPONSIBLE FOR CONDUCTING THE TECHNICAL INVESTIGATION INTO THE ALLEDGED ADVERSE EVENT BECAUSE AT THE TIME THE BUSINESS HAD NOT YET BEEN TRANSFERRED TO INTERA ONCOLOGY PER THE TRANSITION SERVICES AGREEMENT. JOHNSON AND JOHNSON DID NOT PROVIDE THE TECHNICAL INVESTIGATION SUMMARY IN A TIMELY MANNER BUT DID CONFIRM THROUGH EMAIL THAT THE HARDWARE FAILURE 8 CODE WAS FROM FLUID INGRESS INTO THE INTERNALS PUMP. THIS CONCLUSION ALIGNS WITH PREVIOUS INVESTIGATIONS INTO PRIOR HARDWARE FAILURE 8 ERRORS. DUE TO THE DISCONTINUATION OF THIS DEVICE, THERE IS NO MANUFACTURING CORRECTIVE ACTION THAT CAN BE IMPLEMENTED. ADDITIONALLY, THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR INVESTIGATION ON 07/16/2020, RESULTS OF ANALYSIS PENDING. - COMPLAINT (B)(4).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT TO UPDATE THE FOLLOWING: DEVICE WAS IMPLANTED IN YEAR 2014, EXACT DATE UNKNOWN. DEVICE WAS RETURNED FOR INVESTIGATION ON 07/16/2020, RESULTS OF ANALYSIS PENDING.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT TO UPDATE THE FOLLOWING: DEVICE WAS IMPLANTED IN YEAR 2014, EXACT DATE UNKNOWN. DEVICE WAS RETURNED FOR INVESTIGATION ON 07/16/2020, RESULTS OF ANALYSIS PENDING.

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING INVESTIGATED BY JOHNSON AND JOHNSON AS THE MANUFACTURER OF THE DEVICE. INTERA ONCOLOGY, INC ACQUIRED THE LICENSE AND IS CURRENTLY IN A TRANSITION SERVICES AGREEMENT WITH JOHNSON AND JOHNSON FOR ITS OUS MARKET. AS THIS EVENT OCCURED IN (B)(6), JOHNSON AND JOHNSON IS RESPONSIBLE FOR THE INVESTIGATION AND THE LOCAL REPORTING OF THE INCIDENT. HOWEVER, UNDER THE TRANSITION SERVICES AGREEMENT, INTERA ONCOLOGY IS RESPONSIBLE FOR REPORTING IN THE UNITED STATES. JOHNSON AND JOHNSON IS ALSO CONDUCTING THE INVESTIGATION INTO THE INCIDENT, INCLUDING POSSIBLE DEVICE RETURN TO THE MANUFACTURER FOR EVALUATION. TECHNICAL INVESTIGATION OF THE DEVICE NOT YET AVAILABLE; WHEN RESULTS ARE MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    RECEIVED 05/29/2020: A REPORT FROM THE FIELD INDICATED THAT A 40ML MEDSTREAM PROGRAMMABLE INFUSION PUMP (PRODUCT CODE 914201/SERIAL (B)(4)) USED TO DELIVER MORPHINE DISPLAYED A HARDWARE 8 FAILURE. THE PUMP WAS STOPPED, AND MEDICATION WAS SUBSTITUTED. THE PUMP WILL BE EXPLANTED. PUMP TRANSACTION LOGS ARE ATTACHED TO THE COMPLAINT FILE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT. AS LISTED IN THE MEDSTREAM INSTRUCTIONS FOR USE (IFU), PUMP FAILURE IS A KNOWN POTENTIAL EVENT ASSOCIATED WITH THE USE OF INFUSION PUMPS AND CAN RESULT IN A RETURN OF UNDERLYING SYMPTOMS, DRUG WITHDRAWAL SYMPTOMS, DRUG OVERDOSE, OR THE NEED FOR SURGICAL REMOVAL OF THE PUMP. PUMP HARDWARE FAILURE 8 IS HIGH VOLTAGE FEEDBACK ERROR. THE IFU CAUTIONS THE USER TO IMMEDIATELY INVESTIGATE IF THE PUMP ALARM SOUNDS. THE PUMP RESERVOIR SHOULD BE EMPTIED IMMEDIATELY IF THE ERROR MESSAGE IS "PUMP HARDWARE FAILURE (X)". CUSTOMER SUPPORT SHOULD ALSO BE CONTACTED. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE HARDWARE FAILURE. IT IS ALSO UNKNOWN IF THERE WERE ANY CLINICAL SYMPTOMS ASSOCIATED WITH THE HARDWARE FAILURE; THEREFORE, ADDITIONAL INFORMATION IS PENDING AT THIS TIME. SINCE THE PATIENT IS REQUIRING A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE PUMP WILL BE EXPLANTED/REPLACED, THE EVENT MEETS MDR REPORTING CRITERIA AS A "SERIOUS INJURY". HOWEVER, MDR REPORTING IS NOW THE RESPONSIBILITY OF INTERA ONCOLOGY, LLC. (B)(4): PEC: ALARM / BUZZER (MEDSTREAM) - HARDWARE FAILURE - 8. IMDRF CLINICAL SYMPTOMS CODE: NO INFORMATION AVAILABLE. IMDRF HEALTH IMPACT CODE: DEVICE REVISION OR REPLACEMENT. CURRENT RECORD TYPE: PRODUCT COMPLAINT. RECEIVED 06/18/2020: WE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FOR THIS COMPLAINT: WHAT MEDICATION WAS BEING ADMINISTERED THROUGH THE PUMP? MORPHINE. WHAT WAS THE PUMP IMPLANTED TO TREAT? PAIN. IF EXPLANTED AND BEING RETURNED DUE TO MALFUNCTION, WAS THE PUMP EMPTIED UPON EXPLANT? NO! ARE THE PUMP TRANSACTION LOGS AVAILABLE? IF YES, PLEASE FORWARD THEM. YES. DID THE PHYSICIAN STOP THE PUMP AND IF SO, WAS THE PATIENT PUT ON ORAL MEDICATION? YES. PLEASE PROVIDE INITIAL REPORTER (IE. PHYSICIAN, CLINICIAN, ETC) CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, E-MAIL, PHONE NUMBER, FAX NUMBER, AND HOSPITAL/FACILITY ADDRESS: (B)(6). PER FDA REQUEST, PLEASE PROVIDE THE FOLLOWING PATIENT INFORMATION, IF AVAILABLE: AGE/DOB, GENDER: M, WEIGHT, HEIGHT, MEDICAL HISTORY, ALLERGIES, RACE, OR ETHNICITY. IS SUSPECT DEVICE(S) AVAILABLE TO BE RETURNED FOR ANALYSIS. (PROVIDE (B)(6) TRACKING NUMBER IF/WHEN AVAILABLE).YES. ALSO RETURN ANY PRODUCTS USED AS A SYSTEM WITH THE COMPLAINT DEVICE (I.E, THE ASSOCIATED MICROCATHETER, CONNECTING CABLE, SYRINGE, ETC).NO! RECEIVED 06/24/2020: WHAT WAS THE DATE OF THE EVENT? (B)(6) 2020. HAS THE PUMP BEEN EXPLANTED? IF SO, PLEASE PROVIDE DATE OF EXPLANT. (B)(6) 2020. WHAT DOES THE PHYSICIAN THINK CAUSED OR CONTRIBUTED TO THE EVENT? HARDWARE FAYLER 8. WAS THE PATIENT SYMPTOMATIC AS A RESULT OF THE EVENT (IF SO, PLEASE LIST SYMPTOMS)? YES, SYMPTOMS OF DRUG UNDERDOSES. DID THE PUMP SYSTEM APPEAR DAMAGED IN ANY WAY (IF SO, PLEASE EXPLAIN AND SPECIFY COMPONENT)? NO. WHAT WAS THE DATE OF THE PATIENT'S LAST REFILL? (B)(6) 2020. WAS THE REFILL PERFORMED AS PER IFU INSTRUCTIONS (IF NOT, PLEASE EXPLAIN)? YES. WHEN WAS THE NEXT PLANNED REFILL? (B)(6) 2020. WHAT IS THE CURRENT CONDITION OF THE PATIENT? NORMAL. IF YOU ARE UNABLE TO OBTAIN THE PATIENT'S AGE, CAN YOU PROVIDE A "BEST GUESS"? (B)(6) YEARS. PLEASE PROVIDE THE RETURN STATUS OF THE DEVICE? RETURNED TO LOC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656935 MEDSTREAM PUMP 40 ML DRUG INFUSION PUMP LKK INTERA ONCOLOGY 914201

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MORPHINE| MORPHINE| MORPHINE