MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number CSCM

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 results when received. Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

As reported, during use of a finger cuff with the clearsight monitoring system, the finger cuff was providing intermittent readings and inaccurate readings. According to the clinician the values were 80mmhg higher that values obtained with a brachial blood pressure cuff. The shape of the clearsight finger cuff waveform was ¿strange¿ with a long diastolic phase and barely visible dicrotic notch as well as sudden and abrupt "valleys" in both the ci (cardiac index) and the sv (stroke volume) tracings. Several attempts to reposition the finger cuff but with no improvement in the measurements were noted. Once the surgery finished, the physician tested the finger cuff on her own fingers, and the intermittent nature of the measurements was no longer present, although the clearsight readings were still inaccurate by 20-30mmhg as compared to a brachial cuff. There was no information on the shape of the waveform when the physician tested the finger cuff and it is unknown if the finger cuff was the correct size for the physician¿s finger(s). On (b)(6) 2018, sales representative tested the finger cuff on himself and both the continuity and the finger cuff readings worked properly. There was no allegation of patient injury. The product was available for evaluation.

Manufacturer Narrative

One medium clearsight finger cuff was returned for examination. The reported event of "cuff was yielding intermittent measurements" was confirmed from a customer video that was sent. The video showed an unstable pressure reading on the monitor. The pressure readings shown in the video were inaccurate by 20-30mmhg as compared to a brachial cuff. No visible damage was noticed from the returned unit. The pressure cuff inflated without any leakage during leak test. The finger cuff passed eeprom verification but had an expired status. Electrical testing showed that all elements such as shield, led, and photodiode of returned unit worked successfully. A review of the manufacturing records indicated that the product met specifications upon release. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Pressure readings should correlate with the patient¿s clinical manifestations. Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements. The operators manual instructs the use on these above stated factors that can lead to inaccurate values. It is unknown user factors played a role in the stated event. 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: FINGER CUFF
• 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 ; DR
• MDR Report Key: 8021865
• MDR Text Key: 125780527
• Report Number: 2015691-2018-04457
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/13/2020
• Device Model Number: CSCM
• Device Catalogue Number: CSCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No