MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CO-SET INJECTATE PROBE CABLE; 93522

Model Number 93522

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-comformances.

Event Description

It was reported that the 93522 co set cable would not read a temperature of the injectate at all and it would read the temperature low.If the temperature was read low it would give falsely high values for cardiac index output and skew the rest of the hemodynamic profile.When comparing these thermodilution values to the fick cardiac index and output calculated from an svo2 from the same patient it was clear that something was amiss.They knew when they were receiving outputs of 14 to 15 there was no way it was accurate.Patients were not treated based on these numbers.They were able to troubleshoot by exchanging the suspect cable.Patient demographics were unavailable.This was during use.

Manufacturer Narrative

After several attempts made to request product return from the customer, there was no response received for the tracking number.The product was not returned for evaluation.If the product does arrive, a supplemental report will be submitted with the evaluation findings.

• Brand Name: CO-SET INJECTATE PROBE CABLE
• Type of Device: 93522
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15352449
• MDR Text Key: 301656608
• Report Number: 2015691-2022-07694
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 00690103003260
• UDI-Public: (01)00690103003260(17)230210(10)S1908053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1