MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM NON-INVASIVE (NI); SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EV1000NI

Device Problem Incorrect Measurement (1383)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in patient with this ev1000ni (medwatch reference #24452), sytolic blood pressure (sbp) and diastolic blood pressure (dbp) values (sbp 160 - dbp 70) were different to the non-invasive blood pressure (nibp) (125/80).No error message or alarm was observed.The values were reasonable for the patient's clinical condition; they were just different to the nibp.The clinicians ignored the values provided by the ev1000ni in favour of the nibp.As troubleshooting, the cuff size and finger placement were double-checked, and the nibp was adjusted and repositioned; however the issue remained.The arm cuff was on the same side as clearsight.The same issue occurred in the past (medwatch reference #24453), nevertheless no concrete information regarding the values displayed could be obtained.In this case the mean arterial pressure (map) was accurate, so the clinician used this value for treatment.There was no allegation of patient injury.Follow-up has started for device return.As a summary, two medwatch reports were submitted (medwatch reference #24452 and #24453).

Manufacturer Narrative

One ev1000 non-invasive platform was received at original manufacturer for a full evaluation.The report of inaccurate values was unable to be confirmed.The technician was unable to duplicate the set up to see if the arm cuff constriction affects the readings of a finger cuff enough to meet the standards of the warning in the operating manual.The kontron panel had something rattling inside its housing, but it was still able to power up.The panel was connected to a known working system and then attached a patient simulator to the known working pressure controller.The onscreen readings were within the expected range.The simulator was set to 120/80 mmhg and the system read 123/81 mmhg.The tolerance of the simulator is +/- 5 mmhg.The system ran over two hours and the reading never went out of range.Additionally, the databox light pipes were both chipped.On the other hand, the pressure controller (pc2k) was connected to a piek3 clearsight hot mockup system.The pc2k caused no errors.The connected heart reference sensor (hrs) successfully zeroed and the pc2k was able to acquire a normal waveform and blood pressure (bp) readings on both cuff ports.Monitored on each cuff port for one hour and both the systolic and diastolic readings were steady at 120/80 (+/-1 on both readings).No damage was found.As per ev1000 operators manual: "do not apply clearsight finger cuffs on a hand/finger when external constriction (that may prevent circulation to the hand /finger) is present." 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 part of this monthly review.

Manufacturer Narrative

The ev1000 non-invasive platform was not received at our technical service center for a full evaluation.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Based on further evaluation by engineers, upon review of the instructions for use (ifu), it warns the user not to use the arm cuff on the same side as the fingercuff.As this issue is seen by the customer, the potential root cause is associated with user error.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 part of this monthly review.

Manufacturer Narrative

Updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).Further evaluation was completed by the engineers team.The report of inaccurate values was unable to be confirmed.Upon review of the instructions for use (ifu), it warns the user not to use the arm cuff on the same side as the fingercuff and not apply clearsight finger cuffs on a hand/finger when external constriction (that may prevent circulation to the hand /finger) is present.As this issue is seen by the customer, it could be concluded that the failure is likely related to the user not following the ifu.Since the issue was unable to replicate, there was no evicende of product nonconformance or labeling/ ifu inadequacies identified.Regarding the chipped databox light pipes, this condition could potentially be caused by either placing the data box with the light pipes face down, or by repeated contact from inserting the transducer into the transducer holder.Additionally, physical damage to the enclosure could potentially be associated to handling of the device by the end user.However, these findings are not related to the customer reported 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 part of this monthly review.

• Brand Name: EV1000 CLINICAL PLATFORM NON-INVASIVE (NI)
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16059127
• MDR Text Key: 306450607
• Report Number: 2015691-2022-10389
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: EV1000NI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 56 KG