MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CLEARSIGHT TM SYSTEM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number AIQCM

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

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The ifu states the following instructions 1.Use the finger cuff sizing aid by wrapping it around the middle phalanx of the index, middle, or ring finger of the patient and pull the smaller end of the color coded aid through the slot until snug.2.Based on the size indicated on the sizing aid, select the appropriate size finger cuff.Warnings improper placement, sizing, or alignment of the finger cuff can lead to inaccurate monitoring.The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Event Description

It was reported an aiq cuff had low readings compared to a bp cuff.Readings were 90s/40s.Sales rep tried moving the hrs, but saw no changes to the bp.Model and lot number were provided.No patient injury reported.Per follow-up, aiq cuff and bp cuff was used on different extremities.No error messages or alarm accompanied low readings.Cables were checked, but the readings stayed the same.Issue was resolved when the cuff was exchanged to a large.

Manufacturer Narrative

The reported event of pressure reading issue was not able to be confirmed.Finger cuff passed eeprom verification with expired status and patient information.The sensor was reset for pressure test on hemosphere monitor.The 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.Finger cuff bladder inflated and maintain inflation without any leakage during pre deco leak test.The finger cuff sensor also passed post decontamination leak test.The reported event could not be confirmed, as the device responded appropriately during functional testing.Per ifu, improper placement, sizing, or alignment of the finger cuff can lead to inaccurate monitoring.Due to the success on exchanging cuff size from medium to large, this incident was use error and no longer reportable.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 a part of the monthly review.

• Brand Name: CLEARSIGHT TM SYSTEM
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14166752
• MDR Text Key: 291390696
• Report Number: 2015691-2022-05294
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00690103203332
• UDI-Public: (01)00690103203332(17)240115(11)220115(10)64170657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/15/2024
• Device Model Number: AIQCM
• Device Catalogue Number: AIQCM
• Device Lot Number: 64170657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2022
• 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