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

Catalog Number	8713032U
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: propofol pump not dosing properly and blood backing up into the tubing.Pharmacist tried to reprogram the pump and it would not work.
Additional Manufacturer Narrative
This report has been identified as b.Braun mecical inc.Internal report (b)(4).The actual device involved in the reported incident was returned to b.Braun medical for evaluation and the logs were provided for review.Investigation results: the reported issue was not present during investigation.Volumetrics infusion of 100ml/hr and 10ml (dl: prop10) tested in spec at 9.9ml or 99% of e.Performed preventive maintenance service.Log review shows on (b)(6) 2024 and 12:59pm an infusion start of 42ml/hr and 60ml (dl: prop10).At 1:03pm infusion was stopped with a volume infused to 2.84ml.At 1:21pm with a patient weight change from 70kg to 80kg an infusion start of 67.2ml/hr.At 1:25pm with a volume infused to 7.32ml infusion was stopped with no further infusions taking place.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B.BRAUN MELSUNGEN AG; carl- braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18753272
• Report Number: 9610825-2024-00093
• Device Sequence Number: 3837560
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 09/27/2024

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: 8713032U
• Device Lot Number: 97040689J2
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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