MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE OEM MODULE; FORESIGHT ELITE CABLE

Model Number HEMFSM10

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 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for product evaluation; but has not arrived.When the evaluation findings are available a supplemental report will be submitted with the results.The device service history record review cannot be completed as the lot/serial number is unknown.

Event Description

It was reported that there were inaccurate readings obtained during patient use with a foresight elite module cable.The patient was an ecmo patient being monitored in the icu with two foresight cerebral sensors and two somatic sensors on the patient¿s legs, along with a hem1 instrument monitor.The cerebral st02 readings that displayed were in the low 40¿s.The edwards clinical field specialist was present and worked with the clinicians to exchange the sensors at least two times and the cerebral st02 values remained in the 40¿s.They swapped the foresight elite module cable from the a to b location and the readings now read in the high 60¿s.There was no inappropriate patient treatment reported.There was no patient harm or injury.

Manufacturer Narrative

Several attempts were made to request product return and it did not arrive for evaluation.The reported issue could not be confirmed by product evaluation.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.It could not be confirmed if user or procedural factors contributed to the stated 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 part of the monthly review.The device service history record review was completed and all manufacturing inspections passed with no non conformances.The record of servicing has been reviewed and there is no previous related record.The udi is (b)(4).

Manufacturer Narrative

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

• Brand Name: FORESIGHT ELITE OEM MODULE
• Type of Device: FORESIGHT ELITE CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9772131
• MDR Text Key: 191694642
• Report Number: 2015691-2020-10777
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K143675
• 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: 02/07/2020

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: 04/24/2024
• Device Model Number: HEMFSM10
• Device Catalogue Number: HEMFSM10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/03/2020; 07/23/2020
• Supplement Dates FDA Received: 03/18/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1