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

Model Number 4540018-02

Device Problems Excess Flow or Over-Infusion (1311); Air/Gas in Device (4062)

Patient Problems Angina (1710); Foreign Body Embolism (4439)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: a patient's 48hr easypump infused over 30 hours for 2 cycles with possible cardiotoxicity.The patient had a c2d1 folfox.The patient was discharged home with a home infusion pump filled with 5 fu medication and it was supposed to be infused over 48 hours.Per patient, the pump finished after 30 hours and the patient experienced cardiac symptoms: chest pain.He went to er and ekc appeared to be normal.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were submitted to the manufacturer for evaluation.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.If the device does become available, the complaint will be reopened for further evaluation.The complaint is considered not confirmed.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16982574
• MDR Text Key: 315829469
• Report Number: 9610825-2023-00229
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: Health Professional
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 22F17GE561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 06/30/2023
• 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: Initial
• Patient Sequence Number: 1