MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOXSC100; HEMOSPHERE OXIMETRY CABLE

Model Number	HEMOXSC100
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	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned for evaluation.When the product evaluation has been completed, a supplemental report will be submitted.The device history review was completed and all inspections passed with no non-conformances.
Event or Problem Description
It was reported that the hemoxsc100 generated inaccurate numbers.The svo2 would randomly go up and down from the 30s to 60s which did not match the patients stable hemodynamic condition.The nurse exchanged the suspect hemoxsc100 using all the same equipment and the svo2 numbers were stable between 64 and 72.There was no patient injury or inappropriate treatment administered due to the inaccurate numbers.Patient demographics were requested but unavailable.
Additional Manufacturer Narrative
One hemosphere oximetry cable was received for product evaluation.A visual inspection did not find any visible physical damage.The suspect unit was connected to a known good working system and tested per the system verification test.Svo2 values remained within parameters.No fluctuating values were observed.No error messages were observed.There was no defect found.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 the monthly review.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.

• Brand Name: HEMOXSC100
• Common Device Name: HEMOSPHERE OXIMETRY CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12162757
• Report Number: 2015691-2021-04084
• Device Sequence Number: 3768643
• Product Code: DXG
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)200323
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 03/27/2023
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1