MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMOXSC100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
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.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.
Event or Problem Description
As reported, after setting up this hemosphere monitor to be used in a post cardiac surgery patient, just after calibrate this hemosphere oximetry cable, svo2 values promptly dropped from 55% to 18% and did not correlate with the blood gas values.There was no error message was displayed.The swan ganz catheter was repositioned, and then replaced for a new one but the issue remained.Cardiac output and pulmonary artery pressure worked correctly all the time.Then a second hemosphere monitor and cables were used and the issue was solved.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The complaint was not confirmed.From visual inspection no defects were found.As received the cable was plugged into the know good unit hem1 monitor and tested according to internal procedures.No defects were found.After this, the device passed all tests; functional test, run-in and final verification.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The complaint was not confirmed during product evaluation.Additionally, based on the customer report and the fact that no non-conformance was identified during product evaluation, there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors,.

• Brand Name: HEMOSPHERE OXIMETRY CABLE
• 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: 19445631
• Report Number: 2015691-2024-04239
• Device Sequence Number: 8508097
• Product Code: DQK
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)220828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2022
• 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 Age: 70 YR
• Patient Sex: Female