MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE SWAN-GANZ; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Model Number	70CC2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.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 a part of the monthly review.
Event or Problem Description
As reported, the 70cc2 cable malfunctioned during use.The hemosphere monitor showed the blood termpearture rapidly changing from 35 to 45 c.This caused no harm to the patient but caused a delay in obtaining values post-cabg.The customer tried changing out the hemosphere but the issue was not resolved.The customer then tried changing out all the cables and the issue was resolved.There was no physical damage to the cables.The device will be availble for product evaluation.
Additional Manufacturer Narrative
One 70cc2 cable was returned for evaluation.The customer report of inaccurate values was not confirmed.The 70cc2 cable passed the patient cco cable test 3 times on a known working hem1 monitor.It also passed on the cirris cable tester 3 times.The cable was repositioned between each of these tests.The cable was then connected to a known working swan-ganz module and monitoring co was started using a simulator.The co reading stayed within parameters (5.5 - 8.5) and the temperature was normal (98.7f).No errors occurred and no damage to the cable was found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Since no defect was found during evaluation, there was no evidence of product nonconformance or labeling/ifu inadequacies identified.The device history record review was completed and no related non-conformances were found.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.

• Brand Name: SWAN-GANZ
• Common Device Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21402774
• Report Number: 2015691-2025-01108
• Device Sequence Number: 9576367
• Product Code: DXG
• UDI-Device Identifier: 00690103002799
• UDI-Public: 00690103002799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K043103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Model Number: 70CC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown