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

Model Number 8713051U

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

As reported by the user facility: the pump infused faster than it should have.There was patient involvement.The patient complained of discomfort.Patien was monitored.No additional medical actions were taken.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The product involved in the reported incident was returned to one of our b.Braun facilities and the device was evaluated by a qualified technician during the investigation.When the pump was evaluated, the reported issue was not observed.Investigation results: delivery accuracy of 250ml/hr and 25ml tested in spec at 5 minutes 53 seconds or 102% of expected accuracy.Occlusion pressure and air sensor threshold measurements tested in spec.Log review shows on 11/10/2022 and 19:11pm an infusion start of 989ml/hr and 1000ml (dl: ns0.9%).4 pressure alarms occurred during infusion and at 20:15pm with a volume infused to 985.93ml, 2 air alarms occurred with no further infusions taking place that day.On 11/11/2022 and 11:40am an infusion start of 200ml/hr and 1000ml (dl: lr).An air alarm stopped the infusion with a volume infused to 0.42ml.Piggyback was selected and at 11:43am an infusion start of 12.5ml/hr and 4 hours (dl: magnes4).At 11:46am piggyback infusion was stopped with a piggyback volume infused of 0.58ml.No further infusions took place.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4047197287
• MDR Report Key: 15958050
• MDR Text Key: 308108658
• Report Number: 9610825-2022-00510
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713051U
• Device Catalogue Number: 8713051U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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