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

Catalog Number	490038
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: infusomat space pump iv set portless tubing/epidural admin tubing set alarms and does not allow user to infuse critical med (ie: fentanyl).No injury reported.
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.
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 evaluation of the returned sample, the sample was occlusion tested with failing results.To replicate the reported defect, water was passed through the spike and it was noted that fluid would not pass through the second coupler connecting to the space pump assembly.The air in line issue could not be replicated due to the occlusion.Based on the data from the investigation, the reported defect was confirmed.Incidents of this nature are attributed to operator oversight during the solvent application bonding the space pump assembly and coupler to the tubing.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.
Additional Manufacturer Narrative
This follow-up mdr is being submitted with the intention to indicate the following: 1) the investigation findings (c) for this event is 170.2) the investigations conclusion (d) for this event is 23.3) 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.

• 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: 18443560
• Report Number: 2523676-2023-00868
• Device Sequence Number: 7965233
• Product Code: FPA
• UDI-Device Identifier: 04046964185946
• UDI-Public: (01)04046964185946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2024

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: 490038
• Device Lot Number: 0061900137
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 12/13/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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