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

Model Number 4540032-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Inflammation (1932)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).Event 1: the complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Event Description

As reported by the user facility: event 1: same female patient had two incidences of over infusion of 5-fu, ended early.Incident one started (b)(6) 2022 at 3:40 pm finished (b)(6) 2022 11:30 pm.Expected to be 96-hour infusion.Volume in pump 192 ml dose 4800 mg.Patient developed mucositis - interventions required unknown.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned, investigation could not be completed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP®
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13599936
• MDR Text Key: 286341359
• Report Number: 9610825-2022-00049
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448843
• UDI-Public: (01)04046964448843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 4540032-02
• Device Catalogue Number: 4540032-02
• Device Lot Number: 19H02GE631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female