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

Model Number	4540032-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
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 still under investigation.A follow-up report will be provided, as soon as investigation has been completed.
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in germany: "overinfusion" according to the customer: "easypump lt 2ml/h 270ml, ch.Ref.(b)(4).The easypump from the mentioned batch was supposed to run for 5 days (120h), filling 240ml with 5-fu/ nacl 0.9%.However, after about 3 days the pump was completely empty.No user errors are apparent, according to consultation the patient did not "lie on" the pump or otherwise exert pressure on the pump.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4).As no sample and no meaningful picture was provided, proper investigation on malfunction could not be performed.Hence, the complaint is considered as not confirmed.Device history record (dhr): reviewed the dhr for batch 21g27ge341, there is no abnormality and no such defect detected at in process and at final control inspection.

• 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: 14958285
• Report Number: 9610825-2022-00254
• Device Sequence Number: 5831859
• Product Code: MEB
• UDI-Device Identifier: 04046964448843
• UDI-Public: (01)04046964448843(17)260701(10)21G27GE341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/09/2022

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: 07/01/2026
• Device Model Number: 4540032-02
• Device Catalogue Number: 4540032
• Device Lot Number: 21G27GE341
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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