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

Model Number	363410
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	01/24/2020
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: it was reported that while amino acids were running in picc line, the filter leaked slightly.Tachycardia noted.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were provided for evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed and a root cause could not be established.The batch record and our discrepancy management system database could not be reviewed as a lot number was not provided.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INFUSOMAT
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10071874
• Report Number: 2523676-2020-00143
• Device Sequence Number: 14423461
• Product Code: FPA
• UDI-Device Identifier: 04046964294556
• UDI-Public: 04046964294556
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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 Model Number: 363410
• Device Catalogue Number: 363410
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1