MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CABLE CCO CATHETER INTERFACE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	70CC2
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
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 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.
Event or Problem Description
As reported, during use in patient of this 70cc2 cable, the values provided were not accurate according to patient status.The values provided by the cable were compared with the ones provided by a blood gas analysis and they were about 20 points of difference.Exact incorrect values could not be provided.No error message was displayed.There was no allegation of patient injury.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: h2 (type of follow-up report).The device involved in this case was received for evaluation.The report of "inaccurate values" could not be confirmed.From visual inspection, no defects were identified on the cable.As received the cable was connected to a known good unit (kgu) monitor and kgu swan-ganz module, cable test was successfully performed.After this, it was connected to a continuous cardiac output simulator and it was possible to obtain cardiac output values for several hours within range.In addition, the cable was run on the functional tester and it successfully passed the test.Based on further engineering investigation, a definite root cause could not be established for the issue since no defects were found.Based on the available information, there was no evidence of product nonconformance or labeling/ifu inadequacies identified.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.

• Brand Name: CABLE CCO CATHETER INTERFACE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21419047
• Report Number: 2015691-2025-01156
• Device Sequence Number: 9244844
• Product Code: DQK
• UDI-Device Identifier: 00690103002799
• UDI-Public: (01)00690103002799(17)250513(10)S21Y04
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191089
• 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): 04/25/2025

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: 05/13/2025
• Device Model Number: 70CC2
• Device Lot Number: S21Y04
• Was Device Available for Evaluation?: Yes
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown