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

Model Number	8713040U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.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 user facility: event 2: a fentanyl infusion was set to run at 2mcg/kg/hr, and when the pump was checked again, probably within an hour, the rate was 7mcg/kg/hr.No reported injury to the patient.
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).Failure analysis and investigation results confirmed the reported issue.Upon receipt the actual pump involved was visually and functionally inspected.The lcd screen was fluctuating, and the pump was intermittently alarming error codes 1022 and 1111.The cause of the issue was a defective motherboard.The motherboard was replaced, the pump was calibrated, and then the pump was tested and it operated as intended.If additional information becomes available, a follow up report will be submitted.

• Brand Name: PERFUSOR
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 10264702
• Report Number: 9610825-2020-00136
• Device Sequence Number: 3066268
• Product Code: MEA
• UDI-Device Identifier: 04046963687182
• UDI-Public: (01)04046963687182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 8713040U
• Device Catalogue Number: 8713040U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1