MAUDE Adverse Event Report: INTEGRATED MEDICAL SYSTEMS, INC., STERIS CORPORATION IMED EZ FLOW ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number	IM270010L
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Output below Specifications (3004)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/22/2025 complaint update.I suffered the adverse event of not receiving my prescribed antibiotic therapy due to the advocate home infusion pharmacy 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, the (b)(6), installed a picc line and infused the first dose of piperacillin.On (b)(6) 2025, the (b)(6) 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)(6) home care 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 (b)(6) 2025 i spoke with the pharmacist, (b)(6), explained my concerns about the low flow rates and asked what the flow rate specifications are for the pumps.(b)(6) 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)(6) i would prefer to use the elastomeric pumps because of the convenience, as long as they worked properly.On (b)(6) 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)(6).On (b)(6) 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 (b)(6), i spoke to (b)(6) and informed him i had data indicating i had received pumps which did not conform to the flow rate specifications.(b)(6) 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 customerservice@integratedmedsys.Com and shared my data indicating i had received pumps which did not conform to the flow rate specifications.On (b)(6) 2025, i received 7 pumps from the pharmacy.The two pumps i used from this batch exhibited nonconforming low flow rates.On (b)(6) 2025, i spoke with pharmacy manager, (b)(6), explained the issue and shared my flow rate data with him.He promised to fill and deliver pumps from a different lot.On (b)(6) 2025, i received 5 pumps from the ph.Reference reports: mw5169511, mw5169511-1, mw5169512, mw5169512-1 mw5169513, mw5169513-1, mw5169514, mw5169514-1, mw5169515, mw5169515-1, mw5170137, mw5170139, mw5170140, mw5170141, mw5170142, mw5170143, mw5170144, mw5170145.

• Brand Name: IMED EZ FLOW ELASTOMERIC INFUSION PUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): INTEGRATED MEDICAL SYSTEMS, INC., STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• MDR Report Key: 21993280
• Report Number: MW5170138
• Device Sequence Number: 11453288
• Product Code: MEB
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IM270010L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PIPERACILLIN ; TAZOBACTAM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White