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

Model Number	93505
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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.The product has been returned for analysis; however, it has not yet been evaluated.Upon the return of the product a supplemental report will be sent with the investigation results.
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 available for evaluation.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).One device was received for evaluation.The report of cracked connection was confirmed.Multiple cracks were found on female luer of coset flow-thru housing.Leakage occurred from the cracks.No other visible damage was observed from the rest of returned product.Lab findings were aligned with customer photo.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.As part of this investigation it was verified if factor could cause this non-conformance in the manufacturing line.However, a manufacturing issue could not be determined and a definite root cause could not identified.It was concluded that this issue is probably due to use of the device that puts more stress on the unit than intended or expected.Nevertheless, a personnel acknowledgment related to the complaint was provided to the manufacturing personnel.During the manufacturing process there are controls to avoid potential causes related to the related malfunction.

• 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: 19368605
• Report Number: 2015691-2024-03801
• Device Sequence Number: 7678086
• 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): 07/31/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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