MAUDE Adverse Event Report: OUTLOOK®; SET, ADMINISTRATION, INTRA

Model Number	354212
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: event 2: end user reports, "we had two blood infusions that leaked blood from the cassette when the tubing was removed from the pump." no injury reported.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was provided for further evaluation.The sample was functionally leak tested and failed.As a result of this issue, b.Braun has initiated a voluntary medical device correction for multiple batches of outlook® pump sets including the batch identified from this complaint.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.

• Brand Name: OUTLOOK®
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12018297
• Report Number: 2523676-2021-00178
• Device Sequence Number: 11619368
• Product Code: FPA
• UDI-Device Identifier: 04046964293832
• UDI-Public: 04046964293832
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 354212
• Device Catalogue Number: 354212
• Device Lot Number: 0061771274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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