MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	363419
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
As reported by the user facility: air in line."after setting up and priming my line through the pump it would continuously alarm for air bubble." additional: i was required to run a blood transfusion for my patient using the b braun infusion pump.After setting up and priming my line through the pump it would continuously alarm for air bubble yet in assessing the line no air could be identified.Troubleshooting this issue involved: removing the line from the pump and running the line through my fingers to work out any kinks in the tube.Flicking the line to remove any micro bubbles that may be difficult to see.Running my finger along the line inside the pump prior to closing it.Filling the drip chamber with more of the blood, making it fuller.Changing pumps all together and repeating the same tricks, these tricks were attempted numerous times over the course of half an hour before involving the unit educator.The unit educator attempted the same tricks with no success and therefore the educator for iccs was then involved.Wiping the inner sensor with alcohol and letting it dry was the only trick that provided some resolution to the issue, however this needed to be done 3 times throughout the 2 hour infusion in order to complete it.This caused a huge delay in the patient receiving his blood transfusion and a massive waste of time for myself and the 2 colleagues that were involved.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample or lot number was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109
• MDR Report Key: 20543708
• Report Number: 2523676-2024-00957
• Device Sequence Number: 7872671
• Product Code: FPA
• UDI-Device Identifier: 04046964294570
• UDI-Public: (01)04046964294570
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 363419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown