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 Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: "the pharmacy confirmed the drug was prepared as usual and the entire volume (20ml for infusion plus additional ~1.7 ml) was prepped for infusion.The infusion nursing staff confirmed they checked the pump at each vitals sign collection (every 15-20 minutes), and at each previous check no issues were noted.At 16:16 it was first noticed the drug had finished infusing, but at this time the pump read that only 18.22 ml had been infused.The same pump was used for the post-infusion flush.The flush was started at 16:20 and completed at 17:14 despite the fact that the 5ml were programmed to be infused at a rate of 5 ml/hour.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(6).The actual pump involved in the reported incident was returned for evaluation.Volumetric tests were performed with a db 30ml syringe at 5ml/hr for 20ml, and the device tested within specification at 19.94ml, or 99% of the expected volume.Volumetric tests were then performed with a db 10ml syringe at 5ml/hr for 5ml, and the device tested within specification at 4.99ml, or 99% of the expected volume.A review of the device logs was performed.It was noted that at 3:54pm on (b)(6)2020 , an infusion began at 5ml/hr for 20ml.At 7:53pm, the infusion stopped with a volume infused to 20ml.At 8:00pm, an infusion of 5ml/hr for 5ml began, and at 8:53pm, the infusion stopped with a volume infused of 4.43ml.No further infusions took place.The reported incident was unable to be reproduced.The exact nature of the reported event could not be determined at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: PERFUSOR
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 10296101
• MDR Text Key: 199528713
• Report Number: 9610825-2020-00140
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8713030U
• Device Catalogue Number: 8713030U
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1