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

Model Number 4540018-02

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 05/25/2023

Event Type  malfunction  

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.

Event Description

As reported by the user facility: detailed inquiry description: infusion center reported that the easypump had leaked at the filter onto the patient at their home.Patient set up with easypump for 46hr 5fu infusion with lt 270-54-s.Nursing and rx report no apparent issues with product during preparation and setting up on patient.Patients spouse reported leaking once at home with the device.The medication was fluorouracil.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, no damages were detected on the sample.The sample was subjected to a leakage test.The results of the test noted leakage from the air vent of the filter was observed.The reported defect was confirmed.An approved project is in place to further address issues with filter leakage.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, 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: 17134402
• MDR Text Key: 317239863
• Report Number: 9610825-2023-00255
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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