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
Additional Manufacturer Narrative
No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.
Event or Problem Description
As reported, during use, several times in the past, the manifold of this co-set broke.There was no allegation of patient injury.The device was not available for evaluation.Patient demographics were not available.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.The reported malfunction could not be confirmed since no product samples nor images were provided.The possible root cause could be associated to the use of the device or if the part already had cracking symptoms at the time of manufacture, however, since the device was not returned, a more detailed evaluation could not be carried out.Nevertheless, manufacturing personnel was notified about this condition.It was verified that there are manufacturing controls to avoid potential causes related to the reported malfunction.

• 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, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19212722
• Report Number: 2015691-2024-03226
• Device Sequence Number: 6903811
• 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
• Report Date (Section B): 06/11/2024

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?: No
• 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: 06/10/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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