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

Model Number 8713040U

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 10264702
• MDR Text Key: 198860760
• Report Number: 9610825-2020-00136
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 04046963687182
• UDI-Public: (01)04046963687182
• Combination Product (y/n): N
• PMA/PMN Number: K092313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1