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

Model Number 8713051U

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as 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: patient told the doctor in the post op area that she had no pain during her procedure but that she had awareness of what was going on.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).The pump was returned for evaluation.When the pump was evaluated the reported complaint was not confirmed.The delivery accuracy of 250ml/hr and 25ml tested in specification three (3) times: 1st test: 6 minutes 2 seconds or 99% of expected accuracy.2nd test: 6 minutes 2 seconds or 99% of expected accuracy.3rd test: 6 minutes 0 seconds or 100% of expected accuracy.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• 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 18109 ; 4847197287
• MDR Report Key: 12201827
• MDR Text Key: 262623860
• Report Number: 9610825-2021-00294
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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: 35 YR
• Patient Sex: Female