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

Model Number	354216
Medical Device Problem Code	Leak/Splash (1354)
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: it was reported that the rn took down blood tubing and when pump chamber opened, blood was noted to have leaked from tubing cartridge in pump.Small amount noted.Patient completed blood transfusion and flush.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.In order to address the issue of leakage within the cassette portion of the pump sets, b.Braun has initiated a corrective action/preventative action (capa 2021-007-pa) which provides for root cause analysis and corrective action.Additionally, 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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Correction: one (1) photo was provided for evaluation.The photo was visually evaluated and a leak was observed on the horizon cassette in the window weld.In order to address the issue of leakage within the cassette portion of the pump sets, b.Braun has initiated a corrective action/preventative action (capa (b)(4)) which provides for root cause analysis and corrective action.Additionally, as a result of this issue, b.Braun has initiated a voluntary medical device correction for multiple batches of outlook® pump sets.Please read the attached letter in its entirety as it provides you with important information regarding the continued safe use of this product.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: 12323882
• Report Number: 2523676-2021-00276
• Device Sequence Number: 14528406
• Product Code: FPA
• UDI-Device Identifier: 04046964182273
• UDI-Public: 04046964182273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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: 354216
• Device Catalogue Number: 354216
• Device Lot Number: 0061771281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 08/09/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/27/2021; 09/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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