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

Model Number 93522

Device Problem Incorrect Measurement (1383)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Patient demographics unable to be obtained.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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 this monthly review.

Event Description

As reported, during use in patient with this co-set injectate probe cable, it was always indicated the maximum temperature.No further information was available.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Patient demographics unable to be obtained.The cable was received for evaluation.The report could be confirmed.From visual inspection it was observed on the label that the cable is expired since 2023-02-06.The cable was connected to our known good unit hem1 monitor, swan ganz module, 70cc2 cable and cco simulator to reproduce the failure.The error message "fault: ico - injectable temperature out of range, check probe" was displayed measuring ico when the (b)(6) injectable probe cable was connected to the 70cc2 cable.The cable was twisted to check if the error message disappear without success.The cable was measured between pins 1 and 3 according to the device drawing and the value obtained showed a cut on the variable resistance.No temperature values could be obtained.Based on further engineering evaluation, the cable was used outside of useful life.Source of failure could be identified as internal cable failure.

• Brand Name: CO-SET INJECTATE PROBE CABLE
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18594090
• MDR Text Key: 333900644
• Report Number: 2015691-2024-00640
• Device Sequence Number: 1
• Product Code: KRB
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: 02/06/2023
• Device Model Number: 93522
• Device Lot Number: S1908050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1