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

Catalog Number	4540018-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): the complaint is under evaluation.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in switzerland: pm p fluorouracil 3000 mg, 240 ml nacl 0.9% in easypump 5ml/h, 270 ml flexible, ep used: batch 23h08ged91; expiry: 08/2028.Patient l.W.1954: pump fitted on (b)(6) 2024 emptied at 8am on 05.01: patient realised her pump was empty when she woke up in the morning.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr):- reviewed the dhr for batch (b)(4), there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: final control flow rate report of affected batch (b)(4), was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -0.32% and 3.50%.As no complaint sample was received, further investigation is not possible.Summary of root cause analysis: as no complaint sample was received, further investigation is not possible.Therefore, this complaint is considered as not confirmed.Cause : cause could not be determine as no complaint sample was received, further investigation is not possible.Corrections/containment plans with effective date: not applicable corrective actions with effective date: not applicable justification: not confirmed note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: EASYPUMP® II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18794021
• Report Number: 9610825-2024-00109
• Device Sequence Number: 7144051
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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 Catalogue Number: 4540018-07
• Device Lot Number: 23H08GED91
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown