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

Catalog Number	363902
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
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: brief inquiry description: air in line alarms with no air bubbles present.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample was provided for evaluation.Upon visual inspection of the returned sample, no non-conformance was noted.The sample was attached to observe if it would fit into the pump the tubing did not need to be stretched and there was no evidence of interference between the tubing couplers and the pumphousing.To replicate the reported defect of the air-in-line alarm on the pump, the sample were attached to the pump and then tested by running therapy while staggering the rate of flow throughout the therapy.No alarms occurred during the testing of the returned sample.All three samples were also leak tested with no leakages observed.A measurement of the outer diameter of the pump segment tubing was taken and found it meets the specification.The reported defect was not confirmed.Although the defect could not be confirmed, corrective actions were performed to revise specifications which limit unit-to-unit variation in tubing outer diameters and increased the length of the tubing that contacts the air sensor.The reduced variation in tubing outer diameter and length revision improves the coupling between the administration set and the air-in-line sensor reducing the potential for false air-in-line alarms.B.Braun medical inc.Has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured between 01.Jan.2022 and 17.Aug.2023.Corrective actions were performed to revise specifications which limit unit-to-unit variation in tubing outer diameters and increased the length of the tubing that contacts the air sensor.The reduced variation in tubing outer diameter and length revision improves the coupling between the administration set and the air-in-line sensor reducing the potential for false air-in-line alarms.B.Braun medical inc.Has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured between 01.Jan.2022 and 17.Aug.2023.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, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17998764
• Report Number: 2523676-2023-00623
• Device Sequence Number: 5992797
• Product Code: FPA
• UDI-Device Identifier: 04046964294730
• UDI-Public: (01)04046964294730
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 363902
• Device Lot Number: 0061888263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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