MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number	4540018-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pericarditis (4448)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: pump infused faster than expected, while patient was at home.Customer thinks temperature may have affected the infusion."the patient is a 64-year old male.The medication was fluorouracil.The patient was actually being seen in our emergency department due to weakness/stemi and the chemo nurse was asked to come disconnect the iv pump and she reported it was completely done infusing.The pump had been started 1/26 around 2 pm and the nurse removed the pump while the patient was in the ed on 1/27 around 6:30-7 pm.So the pump maybe infused over around 30 hours and was supposed to go for 46 hours." as part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2022-00029, had already been previously submitted timely on 21feb2022.As b.Braun medical, inc.Submitted the manufacturer mdr on behalf of the manufacturer, the importer mdr was inadvertently missed.

• Brand Name: EASYPUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 25563335
• Report Number: 2521402-2026-00656
• Device Sequence Number: 10012533
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638(11)210312(17)260301(10)21C12GE561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026
• Report Date (Section F): 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: 4540018-02
• Device Lot Number: 21C12GE561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/21/2022