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

Model Number	8713080U
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
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: rn in pacu set pca pump to infuse 50ml per md's order.Patient then moved to a nursing floor.When rn was giving report, she noticed the 50mls first programmed was now set to 0.Patient was still able to get intermittent infusions.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual pump involved in the reported incident was not returned to b.Braun's carrollton, tx facility for evaluation.Due to no logs ( device history) nor physical samples we were not able to confirmed reported issue.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual pump involved in the reported incident was not returned to b.Braun's carrollton, tx facility for evaluation.Due to no logs ( device history) nor physical samples we were not able to confirmed reported issue.

• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17106197
• Report Number: 9610825-2023-00237
• Device Sequence Number: 2906098
• Product Code: FRN
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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
• Device Lot Number: 97024333J1
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 05/17/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/29/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown