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

Model Number 363430

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

As reported by the user facility, a leak was reported at the first y connector between the pump and the bag.Leak probably related to a cap attached and not used normally with the y connector.Patient information: an 88 year old male with severe hypotension requiring the addition of other medication.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was provided for evaluation.The sample was visually evaluated, and it was noted the facility had returned a cap belonging to a stopcock in a specimen.It was noted that when using the sample against the product drawing, the cap returned is not used for the reported item.Any use of this cap on the set reported would not work per specification.Based on the evaluation results, the defect was not confirmed to be a manufacturing defect and seemingly caused by the user using a cap that would not work to specification.It should be noted that this is not an adverse event caused by any manufacturing defect or malfunction of the device.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.Defective device is a valuable tool in investigating the cause of this incident.

• Brand Name: INFUSOMAT®
• Type of Device: 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14465777
• MDR Text Key: 292349765
• Report Number: 2523676-2022-00200
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294679
• UDI-Public: (01)04046964294679
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 363430
• Device Catalogue Number: 363430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male