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

Model Number 8713030U

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).Failure analysis and investigation results did not confirm the reported issue.Upon receipt the actual pump involved was visually and functionally inspected.A bd 60ml syringe was loaded three (3) times and functioned correctly each time.Volumetrics of 320 ml/hr and 15.81 ml, and 100 ml/hr and 7.81 ml were performed with standbys and tested in spec.The pump operated as intended and the reported failure could not be reproduced.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.

Event Description

As reported by user facility: when a 60ml syringe was loaded into the pump, the pump immediately pushed 20ml of medication.The line was clamped, so the patient did not receive the 20ml over infusion.

• 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
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 10392230
• MDR Text Key: 202447287
• Report Number: 9610825-2020-00168
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713030U
• Device Catalogue Number: 8713030U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR