MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number UNKNOWN

Device Problem Incorrect Measurement (1383)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

One flotac sensor was received by product evaluation laboratory for a full examination.The report of pressure readings issue was unable to be confirmed.Both flotrac and dpt sensors of the flotrac unit zeroed and sensed pressure accurately on ev1000 and pressure monitor.No error message was noticed on the monitors.During output drift testing of bots sensors of the flotrac units, pressure did not show any drift during output drift testing and met specifications.Electrical testing showed that both input impedance and output impedance for both sensors were within specifications.Zero-offset for both sensors also met specifications.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.

Event Description

As reported, during use in patient, with this flotrac sensor connected to an ev1000 system, there was a difference of 20 mmhg with the systolic blood pressure (sbp) values compare to the ones displayed at the bedside monitor.The exact value displayed and the expected value according the patient status were not available.No error message nor alarm were displayed.The flotrac sensor was changed, however the sbp continued being low.Then, the cables of the ev1000a and the bedside monitors were reconnected and the issue was solved.The patient was not treated according to the wrong values displayed.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.

Manufacturer Narrative

Initially, this event was reported against a flotrac sensor that was received for evaluation and tested on 1st june without any failure found.As per customer clarification on the follow up, the issue remained when exchanging the flotrac for a new one.The problem was solved replacing the flotrac cable and bedside monitor cable.Based on this information and on the flotrac evaluation results, this file has been updated from flotrac to cable unknown.Additionally the event description has been updated as follows: as reported, during use in patient of this ev1000platform using a flotrac cable and a bedside monitor cable, there was a difference of 20 mmhg with the systolic blood pressure (sbp) values compare to the ones displayed at the general electric monitor.The exact value displayed and the expected according to the patient status were not available.No error message nor alarm were displayed.The flotrac sensor was changed without success.Replacing the flotrac cable and bedside monitor cable the issue was solved.The patient was not treated according to the wrong values displayed.There was no allegation of patient injury.Cables had been discarded and it was not possible to clarify if they did not work or there was loose or incorrect connection.Flotrac sensor was sent for evaluation even though as per troubleshooting the issue was likely related to the cables.Device related fields, 510k reference, manufacturer information and investigation codes were updated in in their respective fields.It was further informed that the cables were not available for evaluation since they were discarded at hospital.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.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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: CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 14590054
• MDR Text Key: 298986951
• Report Number: 2015691-2022-06006
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: UNKNOWN
• Device Catalogue Number: MHD6
• Device Lot Number: 64066658
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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