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

Model Number 8713050U

Device Problem Fail-Safe Problem (2936)

Patient Problems Tachycardia (2095); Lethargy (2560)

Event Date 01/21/2021

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.Three (3) infusions were run where a 0.4ml air bubble was introduced into the line, and in all three (3) tests the pump alarmed as intended.The air sensor was tested for air in tubing and fluid in tubing, and all of the measurements were within specification.The device history logs were reviewed and showed that an infusion was started at 11:52 pm, the pump alarmed for air in line at 11:53 pm and this was followed by a 6 second purge.The infusion was started again at 11:53 pm, and at 11:54 pm the pump alarmed for air in line which was followed by 3 purges that lasted for a total of 10 seconds.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: air went into the patient, but there was not an air in line alarm.Patient was moved from the er to the picu.As of (b)(6) 2021, the patient had recovered and returned to baseline.

• 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: 11272427
• MDR Text Key: 258007718
• Report Number: 9610825-2021-00014
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083689
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713050U
• Device Catalogue Number: 8713050U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2012
• 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 Outcome(s): Hospitalization