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 Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been received for evaluation; however, the results are pending.Upon completion of the evaluation a supplemental report will be submitted with the findings.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The servicing records were reviewed and there was no related record of servicing for this unit.The udi is (b)(4).

Event Description

It was reported that during patient monitoring there were inaccurate sv02 readings with the hemosphere oximetry cable.The readings were 99% and then drop to 15%.They would settle at 70-80% after flushing the catheter.Then they would drop to 30-40¿s.This occurred for a few cycles.The suspect oximetry cable was removed and replaced with another oximetry cable and then the numbers displayed as expected.There was no patient harm or injury.There was no inappropriate patient treatment administered.The patient demographic information is not available.

Manufacturer Narrative

One hemosphere oximetry cable was returned for product evaluation.It was connected to known working hemosphere components for analysis and testing.The system verification test was performed.The test was left to run for over 30 minutes.The sv02 values remained within appropriate parameters.There were no error messages that displayed.There was no defect identified.The reported event of inaccurate values was not confirmed by evaluation.It could not be determined if any clinical or procedural factors may have contributed to the issue.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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

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: 8876353
• MDR Text Key: 154164869
• Report Number: 2015691-2019-02946
• 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: 07/19/2019

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: 04/02/2022
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 07/23/2020
• Supplement Dates FDA Received: 08/28/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1