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

Model Number CSCL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 09/27/2019

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 and device history results when received.

Event Description

It was reported that during use, the clearsight finger cuff did not give the same values of systolic, diastolic and mean arterial pressure as the arm cuff or the arterial line.The comparison between the values of the finger cuff and the ones provided by the two other sources were not provided as they were changing according to the procedure.The measurements were not made in the same arm.No error message was displayed.The patient was not treated according to the wrong values.There was no allegation of patient injury reported.Patient demographic were unable to be obtained.

Manufacturer Narrative

One large clearsight finger cuff was returned for examination.The reported event of "wrong values" was not confirmed.No visible damage was noticed from the returned unit.The finger cuff inflated and maintained inflation without leakage during pre-deco leak test.The finger cuff passed eeprom verification with an unused status.The finger cuff zeroed and measured pressure on an ev1000 ni platform without any error message.Electrical testing also showed that all elements such as shield, led, and photodiode worked successfully.A review of the manufacturing records indicated that the product met specifications upon release.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.Correction please see corrected lot number.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 9194626
• MDR Text Key: 195043836
• Report Number: 2015691-2019-03800
• 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: 09/27/2019

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: 09/11/2020
• Device Model Number: CSCL
• Device Catalogue Number: CSCL
• Device Lot Number: 61058969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 07/23/2020
• Supplement Dates FDA Received: 12/16/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1