MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR CABLE CCO CATHETER INTERFACE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 70CC2

Device Problem Incorrect Measurement (1383)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this swan ganz catheter, wrong and varying temperature measurement was displayed.Temperature values went drifty from 37 degrees to 16 degrees, while peripheral temperature measurement in the bladder remained constant.When the difference between these two measurements was bigger than 2 degrees, the swan ganz catheter was shaken and the temperature came back to 37 degrees.There was no allegation of patient injury.

Manufacturer Narrative

The swan ganz catheter was sent to our product evaluation laboratory for a full evaluation.The reported event was unable to be confirmed.As received, no fault messages were showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 37.2 degrees when submerged into a 37.0 degrees water bath.The catheter ran continuous cardiac output (cco) in 37.0 degrees water bath on an hemosphere monitor for 5 minutes with no error.Thermistor and thermal filament circuits were continuous, there were no open or intermittent conditions.No visible inconsistencies were observed on eeprom data.The resistance value of thermal filament circuit was also measured and met specification.All through lumens were patent without any leakage or occlusion.In addition, the balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Lab findings did not match with customer pictures in which is shown a graph sheet of the temperature variation and a bedside monitor displaying temperature.There was also no visible damage was observed from catheter body.The lot number was not available, therefore, the device history record (dhr) could not be reviewed.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.

Manufacturer Narrative

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.Based on further engineering investigation, the units go through inspection process as part of the manufacturing process.

Manufacturer Narrative

Images were provided for evaluation.Based on this review, the image confirms the allegation of temperature values drifting.

Manufacturer Narrative

At the beginning it was unknown if this issue was related to the cco cables or to the swan ganz catheters.Therefore, the event was initially reported as related to the swan-ganz catheter.However, based on the new information received, the cco cable was old and replacing it for new one the issue was solved.Consequently, a supplemental report is being submitted to update the affected model.Based on this, the event description was updated as below: as reported, during use in patient with this cco cable, temperature values drifted from 16 to 37 degrees celsius.Shaking the connection between catheter and cable the issue was solved.Temperature value was compared to the correct peripheral temperature measurement in the bladder.The patient was not treated according to the wrong values provided.There were no error messages displayed.The cco cable was old and replacing it for new one the issue was solved.The cable was not returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.Additionally, the swan ganz catheter was fully evaluated by our product evaluation laboratory and om connector was found broken.This is an unrelated finding to the inaccurate values event; therefore, it was concluded that the swan ganz catheter did not contribute to the event.

• Brand Name: CABLE CCO CATHETER INTERFACE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16513009
• MDR Text Key: 311321382
• Report Number: 2015691-2023-11348
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/07/2023

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 Model Number: 70CC2
• Device Catalogue Number: 774F75
• Device Lot Number: 64647025
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 06/13/2023; 07/06/2023; 08/15/2023
• Supplement Dates FDA Received: 05/09/2023; 07/06/2023; 07/28/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 76 KG