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

Model Number	8713080U
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as 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: a patient's medication (morphine) dosing on pca pump should have been steady but nurse noticed it was changed without authorization.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Although the actual pump involved in the reported incident was not returned, the device history logs were provided for evaluation.Based on the information available in the history logs, the pump functioned as programmed.The dose rate of the pump was changed seven (7) times between when the initial rate was set at 11:37pm on (b)(6) 2021 and when the pump was stopped at 3:49pm on (b)(6) 2021.Each time the rate was changed the data lock was turned off, then once the rate was changed the data lock was reset.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional information becomes available, a follow up report will be submitted.

• Brand Name: PERFUSOR
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11515414
• Report Number: 9610825-2021-00093
• Device Sequence Number: 11774026
• Product Code: FRN
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 8713080U
• Device Catalogue Number: 8713080U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1