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 Code	Gastrointestinal Hemorrhage (4476)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported on mw5096817: patient scheduled on (b)(6) 2020 for folfox chemotherapy.The 46-hour take home fluorouracil dose was compounded in a b braun easypump elastomeric device (270-54-s).The correct drug, the correct drug and base solution volume and correct size/rate elastomeric device was used to prepare the 5fu dose for this patient as confirmed in the compounding camera images.The patient was admitted to the hospital on (b)(6) 2020 with rectal bleeding.Lab tests resulted plt of 9.At 4pm on (b)(6) 2020, it was also noted in the hospitalization record that the elastomeric device was empty.The elastomeric device containing chemotherapy set to infuse over 46 hours was attached on (b)(6) 2020 at 1148am.The device has an accuracy of infusion duration +/- 15% and should have ended between 448am and 348pm on (b)(6) 2020.The elastomeric ran to fast and emptied 11 hours early.Fda safety report id # (b)(4).As part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2020-00261, had already been previously submitted timely on 23oct2020.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: 25563525
• Report Number: 2521402-2026-00664
• Device Sequence Number: 21330943
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638(11)200310(17)250301(10)20C10GE561
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/23/2020

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
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: 4540018-02
• Device Lot Number: 20C10GE561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/23/2020