MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE CLEARSIGHT MODULE

Model Number HEMCSM10

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

The product has been requested to be returned for evaluation; however, it has not yet arrived.When the device has been returned and the evaluation completed the evaluation results will be sent in a supplemental submission.The device history record review was completed and all manufacturing inspections passed with no non-conformances.The udi number is (b)(4).

Event Description

It was reported by the edwards representative that there were inaccurate values with the clearsight module.The values that were received and the values that were expected were not provided.This information was requested and not provided.Per the rep, he reported that it appeared that there was too much pressure coming from the pressure controller.The rep exchanged the pressure controller, but it did not resolve the issue.He received a replacement clearsight module the next day and exchanged it with the suspect unit and then everything worked.The hem1 monitor that was used was upgraded with a different software application and it worked appropriately.There was no patient harm or injury.There was no inappropriate patient treatment reported.Patient demographic information was requested and was not provided.

Manufacturer Narrative

The product was received for evaluation.A visual inspection found that one of the seals inside the wuc socket was damaged.Even though the seal was damaged testing was performed with known good working clearsight components.A patient simulator was also used and set to 120/80 for the measurement.The system read as 121/81 and was in the expected range of plus or minus 5.The system was left to run for over 30 minutes and the readings were always accurate.The reported issue was not confirmed by evaluation; however, there was damage found to the wuc socket on the product.Further evaluation will be performed and any findings that are relevant will be submitted.

• Brand Name: HEMOSPHERE CLEARSIGHT MODULE
• Type of Device: 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: 12817152
• MDR Text Key: 284970852
• Report Number: 2015691-2021-06309
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Device Catalogue Number: HEMCSM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HEM1, PRESSURE CONTROLLER