BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED EZ-FLOW ELASTOMERIC INFUSION PUMP

    MDR report key: 21910682 · Received April 25, 2025

    Report

    Report Number
    MW5169512
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 17, 2025
    Report Date
    May 1, 2025
    Manufacturer
    INTEGRATED MEDICAL SYSTEMS, INC.STERIS CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/6/2025 FOR REPORT MW5169512; 4/22/2025 COMPLAINT UPDATE. I SUFFERED THE ADVERSE EVENT OF NOT RECEIVING MY PRESCRIBED ANTIBIOTIC THERAPY DUE TO THE (B)(4) DISPENSING ELASTOMERIC INFUSION PUMPS WHICH DID NOT CONFORM TO THEIR FLOW RATE SPECIFICATIONS. NEITHER THE PHARMACY NOR THE PUMP MANUFACTURER RESPONDED IN A TIMELY MANNER TO CORRECT THE NONCONFORMANCE. I BELIEVE NEITHER MEDICARE NOR I AM RESPONSIBLE FOR THE COSTS OF THE NONCONFORMING PUMPS ON (B)(6) 2025, DR.(B)(6) ISSUED PRESCRIPTION (B)(6) FOR PIPERACILLIN/TAZO 13.5 GM IN 240 ML NORMAL SALINE TO BE INFUSED AT 10 ML/HR OVER 24 HOURS FOR INITIALLY 14 DAYS AND THEN REFILLED FOR A TOTAL OF 28 DAYS. ON (B)(6) 2025, (B)(4) INSTALLED A PICC LINE AND INFUSED THE FIRST DOSE OF PIPERACILLIN. ON APRIL 3, 2025, (B)(4) DELIVERED 7 FILLED ITEM NUMBER IM270010L EZ-FLOW ELASTOMERIC INFUSION PUMPS MANUFACTURED BY INTEGRATED MEDICAL SYSTEMS, INC., 594 TERRITORIAL DRIVE, BOLINGBROOK, IL 60440. THE PUMPS HAVE 270 ML CAPACITY AND 10ML/HR FLOW RATE. ON (B)(6) 2025, AN (B)(4) NURSE VISITED MY HOME, INSTRUCTED ME ON THE HOME INFUSION PROCEDURE AND STARTED THE FIRST HOME INFUSION. OUT OF CONCERN THAT THE INFUSION COULD BE INTERRUPTED BY A BLOCKAGE IN THE TUBING OR CATHETER, I PERIODICALLY WEIGHED THE PUMPS ON A KITCHEN SCALE WITH 1 GM RESOLUTION, RECORDED THE WEIGHT AND TIME AND CALCULATED THE FLOW RATE. A PRINTOUT OF MY DATA IS ATTACHED. THE FIRST TWO BATCHES, 14 PUMPS, EXHIBITED CONFORMING FLOW RATES. THE TEN PUMPS I USED FROM THE 3RD, 4TH AND 5TH BATCHES OF PUMPS ALL EXHIBITED SIGNIFICANTLY LOWER FLOW RATES. BECAUSE THE THERAPY IS BACK-TO-BACK 24-HOUR INFUSIONS, THERE IS NO OPPORTUNITY TO MAKE UP FOR A LOW FLOW RATE BY EXTENDING THE INFUSION TIME. ON APRIL 19, 2025, I SPOKE WITH THE PHARMACIST, (B)(4), EXPLAINED MY CONCERNS ABOUT THE LOW FLOW RATES AND ASKED WHAT THE FLOW RATE SPECIFICATIONS ARE FOR THE PUMPS. (B)(4) SAID SHE DID NOT KNOW WHAT THE FLOW RATE SPECIFICATIONS FOR THE PUMPS WERE AND SUGGESTED I SWITCH TO AN ELECTRONIC INFUSION PUMP. I TOLD (B)(4) I WOULD PREFER TO USE THE ELASTOMERIC PUMPS BECAUSE OF THE CONVENIENCE, AS LONG AS THEY WORKED PROPERLY. ON APRIL 19, 2025, I CALLED INTEGRATED MEDICAL SYSTEMS, SPOKE TO A RECEPTIONIST, TOLD HER I WAS CONCERNED THE PRODUCTS I WAS USING WERE NONCONFORMING AND ASKED HER FOR THE PUMP FLOW RATE SPECIFICATIONS. HER INITIAL RESPONSE WAS TO REFER ME TO THE PHARMACY. AT MY INSISTENCE, SHE TOOK MY CONTACT INFORMATION AND GAVE ME THE PHONE NUMBER OF THE LOCAL SALES REP, (B)(4). ON APRIL 19, 2025, I VISITED THE INTEGRATED MEDICAL SYSTEMS WEB SITE AND FOUND A DOCUMENT "IMED_EZ-FLOW_FLOWRATEFACTORS_FINAL_121624" WHICH STATED EZ-FLOW PUMPS ARE ACCURATE TO WITHIN +/- 15%. THEREFORE, THE 10ML/HR PUMPS SHOULD DELIVER BETWEEN 8.5 AND 11.5 ML/HR. ON APRIL 19, I SPOKE TO (B)(4) AND INFORMED HIM I HAD DATA INDICATING I HAD RECEIVED PUMPS WHICH DID NOT CONFORM TO THE FLOW RATE SPECIFICATIONS. (B)(4) SAID HE WOULD CONTACT THE PHARMACY AND REPLACE THE PUMPS IN THEIR INVENTORY WITH A DIFFERENT LOT. ON APRIL 22, 2025, I SUBMITTED AN ADVERSE EVENT REPORT TO THE FDA. ON (B)(6) 2025, I VISITED DR. (B)(6). HE SAID THE UNDER DELIVERY OF THE ANTIBIOTIC WAS NOT IDEAL, BUT I WAS MOST LIKELY RECEIVING A DOSE THAT WOULD RESOLVE MY INFECTION. ON APRIL 23, 2025, I SENT AN EMAIL TO [email protected] AND SHARED MY DATA INDICATING I HAD RECEIVED PUMPS WHICH DID NOT CONFORM TO THE FLOW RATE SPECIFICATIONS. ON APRIL 23, 2025, I RECEIVED 7 PUMPS FROM THE PHARMACY. THE TWO PUMPS I USED FROM THIS BATCH EXHIBITED NONCONFORMING LOW FLOW RATES. ON APRIL 24, 2025, I SPOKE WITH PHARMACY MANAGER, (B)(4), EXPLAINED THE ISSUE AND SHARED MY FLOW RATE DATA WITH HIM. HE PROMISED TO FILL AND DELIVER PUMPS FROM A DIFFERENT LOT. ON APRIL 26, 2025, I RECEIVED 5 PUMPS FROM THE PH. REFERENCE REPORTS: MW5169511, MW5169511-1 MW5169513, MW5169513-1, MW5169514, MW5169514-1, MW5169515, MW5169515-1, MW5170137, MW5170138, MW5170139, MW5170140, MW5170141, MW5170142, MW5170143, MW5170144, MW5170145.

    Description of Event or Problem · 0

    FIVE ELASTOMERIC HOME INFUSION PUMPS FAILED TO DELIVER THE DESIGN FLOW RATE. DR. (B)(6) PRESCRIBED HOME INFUSION OF 13.8 GM PIPERACILLIN/TAZO IN 240 ML OF NORMAL SALINE INFUSED OVER 24 HOURS FOR 28 DAYS TO TREAT A BONE INFECTION. (B)(6) INSTALLED A PICC LINE. (B)(6) PROVIDED INTEGRATED MEDICAL SYSTEMS, INC., 800.755.3800, 594 TERRITORIAL DRIVE BOLINGBROOK, IL 60440 IM270010L 270 ML CAPACITY, 10ML/HR FLOWRATE ELASTOMERIC INFUSION PUMPS. TO INSURE I WAS RECEIVING THE PRESCRIBED THERAPY, I WEIGHED THE PUMPS BEFORE USE AND PERIODICALLY DURING THE THERAPY. THE PRODUCT LITERATURE STATES THE PUMPS ARE ACCURATE WITHIN 15% OF RATED FLOW RATE. THE FIRST 14 PUMPS WORKED WELL, DELIVERING OVER 90% OF THE PRESCRIBED VOLUME WITHIN 24 HOURS. BEGINNING WITH THE 15TH PUMP, LOT NUMBER S24M079, THE AVERAGE INFUSION FLOWRATE WAS BETWEEN 7 AND 8 ML/HR, RESULTING IN INCOMPLETE DELIVERY OF THE THERAPY WITHIN 24 HOURS. I FLUSH THE PICC LINE WITH 20 ML OF SALINE EACH DAY WHEN CHANGING THE PUMP WITHOUT ISSUE. I LET ONE PUMP DISPENSE INTO MY SINK TO SEE IF THE PICC LINE WAS OBSTRUCTING FLOW. THE PUMP FLOW RATE WAS UNDER 7 ML/HR. I EXPRESSLY GRANT THE FDA ACCESS TO ALL MY MEDICAL RECORDS FOR THE PURPOSE OF INVESTIGATING THIS ISSUE. I CAN PROVIDE PUMP WEIGHT DATA UPON REQUEST. REFERENCE REPORT MW5169511, MW5169513, MW5169514, MW5169515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428341 IMED EZ-FLOW ELASTOMERIC INFUSION PUMP PUMP, INFUSION, ELASTOMERIC MEB INTEGRATED MEDICAL SYSTEMS, INC.STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other PIPERACILLIN | TAZOBACTAM