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

Model Number 93522

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, during use in patient with this co-set injectable probe cable, cardiac output (co) was displayed higher than expected.Based on this, the patient was treated incorrectly and there was harm to the patient.The device was available for evaluation.Patient demographics were requested and unable to be obtained.Follow-up has started for device return.

Manufacturer Narrative

One cable was received by our product evaluation laboratory for a full examination.The report of inaccurate values could be confirmed.The device was received by our technical service center for a full examination.From visual inspection it was observed the cable was expired.The cable was tested with workshop known good unit hemosphere monitor, swan ganz module and 70cc2 cable to reproduce the failure.The system was connected together and bolus option could not be performed as temperature could not be detected.The error message "fault: ico-injectable temperature out of range, change probe" was displayed.Cable was twisted to check if there is internal damage but no values could be obtained.Resistance measured between pin 1 and 3 was 15.5 k ohms, at room temperature of 25 degrees celicius, temperature was variated but no changes were registered on resistance.The expected value provided by the original manufacturer is 65kohms at room temperature.In addition, the expected behavior should be that resistance would increase in case the thermistor was cooled which does not occur with customer's cable.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation, the source of the failure could be determined to be an internal cable failure and the device being used outside of useful life.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.

• Brand Name: CO-SET INJECTATE PROBE CABLE
• Type of Device: CO-SET INJECTATE PROBE CABLE
• 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 ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16155729
• MDR Text Key: 307260917
• Report Number: 2015691-2023-10136
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Device Lot Number: S1604039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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