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

Model Number	N/A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2022
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 china "overinfusion." administration of 0.9% sodium chloride injection 126 ml + human endostatin injection 3 ml for 72 hours.The infusion was performed at 2 ml/hour/day.At 13:00 on august 26, the nurse prepared the patient according to the above doctor 's advice (it was expected to end at 13:00 on (b)(6).However, at 22:00 on (b)(6), the nurse checked the infusion.Nurse reported that infusion has been finished 15 hours earlier than expected.
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4).As no sample was provided, an examination and root cause analysis was not possible at our service laboratory.According to the error description no further analyses could be performed.The information provided has been entered into our complaint database and will be included in our trend analysis of this product line.The complaint will be assess as not confirmed.

• Brand Name: EASYPUMP II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 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: 15579352
• Report Number: 9610825-2022-00409
• Device Sequence Number: 6498877
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)261201(10)21N02GE221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062700
• 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
• Report Date (Section B): 10/11/2022

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: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 4540032
• Device Lot Number: 19C27GE341
• 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: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown