MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERFUSOR®; PUMP, INFUSION

Model Number	8713032U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as (b)(4).Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: the syringe pump infused the right volume, but just at a faster time then what was wanted.Patient injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The product involved in the reported incident was returned to one of our b.Braun facilities and the device was evaluated by one of our qualified technician in the investigation.When the pump was evaluated, the reported issue was observed therefore confirmed.Syringe holder piston/blade was not coming out and the pump was not recognizing the correct syringe.As a corrective action our investigation team replaced syringe holder with piston brake and performed a technical safety check.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15078140
• Report Number: 9610825-2022-00282
• Device Sequence Number: 17348931
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: 8713032U
• Device Catalogue Number: 8713032U
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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