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

Model Number 8713030U

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: infusion still has ~8ml remaining in the syringe even though the pump indicates that 19ml has been administered.The syringe was filled to 21ml.

Manufacturer Narrative

Exemption number e2016018.B.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).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.Three (3) volumetrics of 100 ml/hr were performed with a 30ml bd syringe, and all of the test results were within specification.The pump operated as intended and the reported failure could not be reproduced.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.It should be noted that a log review indicated that both a 30ml bd syring and a 50ml bd syringe had been confirmed for infusions.The instructions for use state that, "syringe must be mounted with flange upright into the slot," and a warning label is placed on the inside of the syringe holder giving indication of this.In addition, the ifu states that, "prior to starting an infusion, verify that the syringe size and model on the syringe pump's display screen match the syringe size and model that were loaded into the pump." if the correct syringe is not confirmed it can result in a false volume delivered.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: 8353191
• MDR Text Key: 136603027
• Report Number: 9610825-2019-00020
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (y/n): N
• PMA/PMN Number: K092313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: 03/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2019
• Distributor Facility Aware Date: 01/28/2019
• Device Age: 1 YR
• Date Report to Manufacturer: 03/29/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1