MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR CLEARSIGHT FINGER CUFF MEDIUM; CUFF, BLOOD PRESSURE, SINGLE USE

Model Number CSCM

Device Problem Incorrect Measurement (1383)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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 this monthly review.

Event Description

As reported, during use in patient before surgery with this finger cuff, the blood pressure value repeatedly drifted after being provided in a stable way, while patient condition remained unaltered.Patient was not treated according to these values.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Added information to d4 (lot number and expiration date) d9 and h4 (device manufacturer date).Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).The finger cuff was received for a full examination.Report of pressure issue was not able to be confirmed on returned device.Finger cuff passed eeprom verification with unused status.Finger cuff zeroed and sensed pressure on hemosphere monitor without any error message.Electrical testing showed that all elements such as shield, led, and photodiode of returned unit were ok.No visible damage was noticed from the returned unit.The finger cuff sensor passed post-decontamination leak test.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The device was used consecutively with another finger cuff related to manufacture ref (b)(4).

• Brand Name: CLEARSIGHT FINGER CUFF MEDIUM
• Type of Device: CUFF, BLOOD PRESSURE, SINGLE USE
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18581171
• MDR Text Key: 334771609
• Report Number: 2015691-2024-00581
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CSCM
• Device Lot Number: 64010376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1