MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE

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 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.The evaluation findings are not yet available.When the evaluation is completed a supplemental report will be submitted with the results.The device service history record review is pending.When the results are available a supplemental report will be submitted with the results.(b)(4).

Event Description

It was reported that there were variations in the sv02 values with the hemosphere oximetry cable.This was during patient monitoring.The values were from 69% to 38% and 90% to 30% to 40%.The hemosphere monitor was ruled out as suspect as the issue was isolated to the cable only.There was no inappropriate patient treatment administered.There was no patient harm or injury.Demographic information not available at this time.

Manufacturer Narrative

One hemosphere oximetry cable was returned for product evaluation.The cable was tested per the system verification test and left to run for one hour.The sv02 values remained within appropriate parameters.There were no error messages observed.The functional testing was performed and it passed the test.A visual inspection was conducted and there was no external physical damage identified.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 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, oximetry 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: HEMOSPHERE OXIMETRY CABLE
• Type of Device: HEMOSPHERE OXIMETRY CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8292516
• MDR Text Key: 135151310
• Report Number: 2015691-2019-00327
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

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: 11/08/2021
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 07/23/2020
• Supplement Dates FDA Received: 02/21/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1