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

Model Number	93522
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional 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-conformances.
Event or Problem 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.
Additional 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
• Common Device Name: 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: 15352416
• Report Number: 2015691-2022-07691
• Device Sequence Number: 6002834
• Product Code: KRB
• UDI-Device Identifier: 00690103003260
• UDI-Public: (01)00690103003260(17)230409(10)S1910083
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K811399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2023
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown