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

Model Number	93505
Medical Device Problem Codes	Fluid/Blood Leak (1250); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Patient demographics unable to be obtained.It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.
Event or Problem Description
As reported, when injecting the bolus to measure cardiac output, the co-set manifold was found to have a crack at the female luer and saline leaked.Therefore, cardiac output values were 8.5l/min, while as per patient's condition it should be 6l/min.Replacing the co-set manifold the issue was solved.There was no allegation of patient injury.The device was not available for evaluation.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
The device involved in this complaint was not available for evaluation since it was discarded.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.There are manufacturing controls to avoid potential causes related to the reported malfunction as visual inspection by manufacturing on station and sampling for visual inspection by manufacturing.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Edwards will continue to review and monitor all events.

• Brand Name: CO-SET PLUS FLOW-TRU HOUSING
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19357235
• Report Number: 2015691-2024-03777
• Device Sequence Number: 20436844
• Product Code: KRB
• UDI-Device Identifier: 07460691949973
• UDI-Public: 0107460691949973010746069194997317280829112308311065281866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K771663
• 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): 07/10/2024

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
• Device Model Number: 93505
• Device Lot Number: 65281866
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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