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

Model Number	4540008-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incide a review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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.
Event or Problem Description
As reported by the user facility: description: our infusion center had a patient report leakage.Patient had "wet shirt" when returned for removal next day.The morning of appointment for the patient's pump disconnect patient noticed that there was a wet spot on clothing when patient woke up.Patient came to cancer center immediately (4-6 hours early for scheduled disconnect) with pump wrapped in a towel.Nurse noticed that the towel was wet but did not see the active leak.Patient stated that leak occurred on tubing at junction with disk marked 10 ml/h (junction closest to the elastomeric ball not junction closest to patient access port).No injury reported.

• Brand Name: EASYPUMP
• Common Device Name: 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: 16976331
• Report Number: 9610825-2023-00228
• Device Sequence Number: 20443745
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: 4540008-02
• Device Catalogue Number: 4540008-02
• Device Lot Number: 22K18GE512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown