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

Model Number	8713030U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
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: customer states that the anesthesiologist set up the pump using the drug library, she chose propofol.10mg/30ml, entered the patient weight of 61kg and pressed start.A few minutes later the pump alarmed, and she noted that the syringe was empty and the entire volume had been infused.The anesthesiologist was able to duplicate this with saline for the customer.Customer states she (health professional) chose "change syringe" on the pump, hit start and the saline just "poured right out".Customer was not able to duplicate this himself, it is suspects it could be user error but the pump will still be evaluated to make sure it is functioning properly.No patient harm due to this.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Investigation results: the reported issue was not present during investigation.Multiple attempts to replicate customer infusions did not allow the pump to accept rates greater than 200ml/hr.Volumetrics of 100ml/hr and 10ml tested in spec at 9.84ml or 98% of expected accuracy, perform preventive maintenance service including replacement of motherboard #34520880 for memory/data retention issue.Log review shows on 2/23/2022 a pump calibration followed by power-on at 11/15/2022 and 7:39am an infusion start of 60ml/hr and 10ml.At 7:39am infusion was stopped with a volume infused to 0.19ml, followed by special function drug library/no preset value prop ga, with dose rate calculation 10mg/30ml; patient weight 59kg; dose rate 50.65mcg/kg/min or 537.9ml/hr then pump powered-off.Pump was powered-on, reset therapy selected, and at 8:48am an infusion start of 999.8ml/hr (91.05mcg/kg/min).At 8:48am infusion stopped with a volume infused of 10ml.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION, PCA
• 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 ; 4047197287
• MDR Report Key: 15926857
• Report Number: 9610825-2022-00504
• Device Sequence Number: 12041341
• Product Code: MEA
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 8713030U
• Device Catalogue Number: 8713030U
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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