MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE

Model Number HEMOXSC100

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

The oximetry cable has not been received for evaluation.It is expected to be returned; however, it has not yet arrived.Once it has arrived and a product evaluation has been completed, the findings will be submitted in a supplemental report.The device history record review was completed and all manufacturing inspections passed with no non-conformances.Udi (b)(4).The submission number for the other occurrence will be provided in a supplemental report.

Event Description

It was reported that the hemosphere oximetry cable displayed values that were different numbers than the lab values and different readings from other cables and monitors.The sv02 reading was in the 30's.The venous gas reading was in the 60's.They re-calibrated and checked the position of the swan catheter and there were still low sv02 readings that did not make sense in relation to the patient's condition.When they exchanged the suspect cable for another one and calibrated, then the sv02 reading made sense in regard to the patient picture.The oximetry cable was identified to be the contributor to the issue.The clinician told the edwards clinical field representative this issue had occurred before with this cable.An mdr report will be submitted for that event.There was no patient harm or injury.There was no inappropriate patient treatment administered.The patient demographic information is not available.

Manufacturer Narrative

One oximetry cable was received for product evaluation.The device was connected to a known good working system for product evaluation.The invitro calibration test was performed and there were no issues found.The values displayed were as expected.The system was left to run for around 3 hours.The sv02 reading displayed with values as expected.The invitro calibration test was performed and the system was left to run for another 3 hours.The sv02 reading was also as expected.A visual inspection was performed and there was no physical damage identified.There was no defect found.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 part of the monthly review.The reported event was not confirmed by evaluation.It could not be determined if any clinical or procedural factors may have contributed to the event.Refer to the other submission for the same oximetry cable, different occurrence date, 2015691-2020-14153.

• 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: 10744544
• MDR Text Key: 213683017
• Report Number: 2015691-2020-14152
• 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
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1