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

Model Number CSCL

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

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.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

During use of this clearsight finger cuff it was reported that there was a constant difference in values between the clearsight finger cuff and the brachial arm cuff.The difference in the systolic values was of 20-30mmhg, while the difference in the diastolic values was of 15-30mmhg.The values displayed by the arm cuff were 157/84, 171/81, 135/64, 190/93, 129/68, while the values displayed by the clearsight were 132/62, 128/61, 99/48, 172/74, 85/43.In addition, it was stated that 90% of the time the arm cuff was providing the correct values as per user opinion however, these values were not compared with any other source in order to verify which values were correct.The values with the two devices were taken from different arms (as stated in the ifu) and the patient was not treated with any medication based on the incorrect values.There was no error message displayed, except for low value alarms.Patient details were not involved.There was no allegation of patient injury.The product was available for evaluation.

Manufacturer Narrative

One large size finger cuff was returned for examination.The reported event of inaccurate values with the finger cuff was not able to be confirmed.No visible damage was noticed from the returned unit.The pressure cuff inflated without any leakage during a pre-decontamination leak test.The finger cuff passed eeprom verification.Electrical testing also showed that all elements such as shield, led, and photodiode of returned unit worked successfully.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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 if user or procedural factors played a role in the stated event.In this event, no patient compromise was reported.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CLEARSIGHT 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: 8928155
• MDR Text Key: 196411957
• Report Number: 2015691-2019-03161
• 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: 08/02/2019

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 Expiration Date: 12/09/2021
• Device Model Number: CSCL
• Device Catalogue Number: CSCL
• Device Lot Number: 61773849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 07/23/2020
• Supplement Dates FDA Received: 09/30/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1