MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CO-SET PLUS FLOW-TRU HOUSING; PROBE, THERMODILUTION

Model Number	93505
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, the manifold of this co-set broke.There is no allegation of patient injury.Patient demographics were not available.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Additional Manufacturer Narrative
Added information to section d9 and h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for a full evaluation.The report of co-set broken was confirmed.The male luer of coset flow-through housing had been completely broken.Broken male luer was not returned.Cross surface of broken luer was rough and uneven.No other visible damage was observed from returned unit.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The cause of the issue could be traced to device desing.The male luer meets all specifications and aligns with customer requirements, however the issue is caused when the user puts more stress on the male luer than intentened.Corrective actions are being implemented in order to eliminate the cause of the non-conformity and prevent recurrence of this type of complaint.
Additional Manufacturer Narrative
Updated section h6 (device code) to better reflect the nature of the event.

• Brand Name: CO-SET PLUS FLOW-TRU HOUSING
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19213290
• Report Number: 2015691-2024-03227
• Device Sequence Number: 8017303
• Product Code: KRB
• UDI-Device Identifier: 07460691949973
• UDI-Public: (01)07460691949973(17)270605(11)220606(10)64390628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K833997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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 Model Number: 93505
• Device Lot Number: 64390628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 07/17/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/08/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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