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

Model Number HEMOXSC100

Device Problems Incorrect Measurement (1383); 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 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The unit is expected to be returned for analysis; however, it has not yet been received.Upon the return of the unit, a supplemental report will be sent with the investigation results.Additionally, a device history record review has been initiated to ensure that the device met all specifications upon distribution and there are no previous service record findings.(b)(4).

Event Description

It was reported that during use there were drifting values noted with the hemosphere oxsc cable.The clinician could perform an initial in-vivo calibration at 64%; however, after 1-3 hours it drifted lower.The clinicians questioned the values because the drift did not correlate to the patient condition or symptoms; therefore, the patient was not treated off of the values on the monitor.There was no patient harm or injury reported.Patient demographics were requested and not provided.

Manufacturer Narrative

A hemosphere oximetry cable was received for evaluation.The cable was tested per the system verification testing.It was observed and left to run for 27 hours.The sv02 values were within appropriate parameters.There were no error messages identified.The cable passed the fct3 testing.The device diagnostic log was reviewed and it did not identify any faults or errors that would contribute to the device failure.An external inspection was performed and there was no visible physical damage found.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue of inaccurate values was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the issues; therefore no corrective action was taken.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.In this case it is unknown if user or procedural factors played a part in this event.There was no patient compromise noted in this 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.

Manufacturer Narrative

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

• Brand Name: OXSC
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8147635
• MDR Text Key: 130201631
• Report Number: 2015691-2018-05179
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2018

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: 02/12/2021
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Device Lot Number: 13701582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 07/23/2020
• Supplement Dates FDA Received: 01/29/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1