MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMTOM10; HEMOSPHERE TISSUE OXIMETRY MODULE

Model Number	HEMTOM10
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	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-conformances.
Event or Problem Description
It was reported that the hemtom10 has been generating intermittent and fluctuating sto2 values.The issue has been with the a1 l values.The a2 r value stayed steady from 88 89 during a case.When there is a value the a1 l value fluctuated between 65 to 88 changing every few seconds.After a few minutes of displayed values the a1 l suddenly stops generating values.After several minutes the cycle starts again.This was during use.There is no patient injury.Patient demographics were requested but unavailable.A hem1 hemfsm10 and foresight sensor will also be sent in separate mdrs.
Additional Manufacturer Narrative
One hemisphere tissue oximetry module was returned for evaluation.They connected the module to a known working system and began monitoring using sto2 simulators.They were able to use both the a and b ports with no issues.They ran each port for 30 minutes.The sto2 readings were accurate and remained steady.There was no defect found.
Additional Manufacturer Narrative
Please refer to these submission numbers: 2015691-2022-07154 for the hemfsm10, 2015691-2022-07156 for the hemtom10, 2015691-2022-07152 for the hem1, and 2015691-2022-07153 for the foresight sensor.

• Brand Name: HEMTOM10
• Common Device Name: HEMOSPHERE TISSUE OXIMETRY MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15161315
• Report Number: 2015691-2022-07156
• Device Sequence Number: 5553590
• Product Code: DXG
• UDI-Device Identifier: 00690103200355
• UDI-Public: (01)00690103200355(11)210610
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 06/11/2026
• Device Model Number: HEMTOM10
• Device Catalogue Number: HEMTOM10
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 09/12/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/11/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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 Sex: Unknown