MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE CLEARSIGHT MODULE

Model Number	HEMCSM10
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	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were inaccurate blood pressure readings that displayed with the clearsight module.During patient use.The system monitoring equipment was setup by the edwards representative.The patients blood pressure reading when monitoring the nibp was systolic 240.The radial arterial line reading was systolic 220.The aiq cuff blood pressure reading was systolic 130 to 150.The edwards representative was present and asked to recycle the bp.The patient placement for all three were on the same extremity, right arm.The procedure was a cea.During the procedure there was squirting of blood from the carotid artery.The blood loss quantity estimation is 200ml.There was no treatment for the blood loss.The patients post operative condition was fine,.There was no patient harm or injury.There was no inappropriate patient treatment administered.Patient is female, no other demographics available.The rep received a replacement clearsight module and used it for another case and there were no further issues.
Additional Manufacturer Narrative
The device has been requested for return for evaluation, but has not yet arrived.When the evaluation has been completed and the findings available, a supplemental submission will be sent with the results.The device service history record review was completed and all manufacturing inspections passed with no non conformances.There were three other incidents with this same clearsight module that occurred at the hospital.Those incidents will be submitted separately in an mdr.The submission numbers will be sent in a supplemental follow up report when available.
Additional Manufacturer Narrative
The product has been requested for return, but has not arrived.Once the product has been returned and the product evaluation completed the findings will be submitted in a supplemental submission.There are four occurrences with this same clearsight module.The mdr submission numbers to link them are; 2015691-2023-11283, 2015691-2023-11284, 2015691-2023-11286, 2015691-2023-11287.
Additional Manufacturer Narrative
The module was returned and received for product evaluation.The unit was connected to a known good working hemisphere instrument for testing.There were normal blood pressure readings and a normal waveform that occurred.The system was left to run for 30 minutes and the readings remained stable.A visual inspection found no damage to the unit.The reported issue was not confirmed.

• Brand Name: HEMOSPHERE CLEARSIGHT MODULE
• Common Device Name: CLEARSIGHT 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: 16492009
• Report Number: 2015691-2023-11287
• Device Sequence Number: 5912486
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)211109
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2023

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: HEMCSM10
• Device Catalogue Number: HEMCSM10
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 05/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/14/2023; 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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: Female