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

Model Number	8713080U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
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 inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to get additional information are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: when the patient was discharged, the remaining volume in the syringe was 19ml, but the pump indicated that there should be 29.98ml remaining to be infused.The infusion was started with a 50ml bd syringe.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned; however, the device history logs were provided for evaluation.When the logs were evaluated it showed that 29 1ml pca infusions and 2.52 ml pca infusions occurred from 9:49pm on (b)(6) 2021 until 4:38pm on (b)(6) 2021; with a total volume infused of 29.98ml.Without the actual device a thorough analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 11847558
• Report Number: 9610825-2021-00172
• Device Sequence Number: 3724294
• Product Code: FRN
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1