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 02/16/2023

Event Type  malfunction  

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.

Event Description

It was reported that there was a failure with the clearsight module, during patient use.The aiq cuff was being used to monitor the patient's blood pressure reading.The reading was ten points off when compared to the nipb measurement.The exact reading of what was displayed and what was expected is not available.The issue was isolated to the clearsight module.When they received a replacement clearsight module they used it with the same other equipment and everything worked as intended.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographics were requested and are not available.

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.

Manufacturer Narrative

The module was returned and received for product evaluation.The unit was connected to a known good working hemosphere 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
• 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: 16491903
• MDR Text Key: 310803022
• Report Number: 2015691-2023-11283
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)211109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 05/15/2023
• Supplement Dates FDA Received: 03/14/2023; 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1