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

Model Number CSCM

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

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patients 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 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.

Event Description

It was reported that with a clearsight finger cuff there was a case of high bp discrepancy (mean arterial pressure) compared to nibp.There was no error message displayed.It is unknown what values were provided and what were the expected values according to the patient's clinical condition.The values were compared to a brachial blood pressure cuff, also those values are unknown.The patient did not receive treatment based on the wrong values.According to the sales rep, it could be due to incorrect cuff positioning on finger and brachial, different arms for cuff positions, or in patient temperature in extremities.There was no allegation of patient injury.The clearsight finger cuff was not available as it was discarded.Patient demographics were unable to be obtained.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 11582453
• MDR Text Key: 243287257
• Report Number: 2015691-2021-02116
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSCM
• Device Catalogue Number: CSCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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