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

Model Number	4540008-02
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in australia: "overinfusion" reason of complaint: pump ran empty after 12 hours.Pump filled with ceftiaxone to infuse, over 24 hours.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report (b)(4).The actual device involved in the reported incident was returned for evaluation.The reported issue of underinfusion was not present during investigation.Volumetrics of 100ml/hr and 10ml tested in spec at 9.9ml or 99% of expected volume.Perform preventive maintenance service.Log review confirms da 1222 error.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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® II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsunge
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14960951
• Report Number: 9610825-2022-00270
• Device Sequence Number: 20241838
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)261001(10)21L11GE221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 21L11GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 06/29/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 11/09/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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