MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXMK2041

Device Problems Contamination (1120); Material Discolored (1170)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

One pressure monitoring set was received by our product evaluation laboratory for a full examination; however, the device evaluation has not yet been completed.Upon completion of the product evaluation a supplemental report will be sent with the investigation results.

Event Description

As reported, when preparing these two pressure monitoring sets (medwatch ref #(b)(4) and #(b)(4)) before surgery, the transparent saline solution used to flush the devices turned pink.Another pair of sets were used instead.Both sets were from the same box.The same issue did not occur with other sets taken from another box having the same lot.As per hospital process the pressure monitoring sets for the whole or are prepared together to be used on the same day so although a specific patient was not involved the user planned to use these sets on a patient or patients eventually.The devices are available for evaluation.

Manufacturer Narrative

One pressure monitoring set received by our product evaluation laboratory for a full examination.The report of "the transparent saline solution used to flush the device turned pink" was unable to be confirmed.As received, there was liquid inside the entire length of the pressure line (coiled and distal lines).Liquid was flushed out and appeared to be transparent in color.However, the red striped pressure tubing from dpt housing to stand-alone stopcock (coiled line) was found tinged in pink.The red striped pressure tubing from stand-alone stopcock to the end of the pressure line (distal line) was not tinged in pink and appeared transparent as usual.Coiled pressure line remained pink after the liquid inside was flushed out.Coiled pressure tubing was flushed with lab saline and remained pink.Flushed out lab saline appeared transparent in color.Distal pressure tubing was also flushed with lab saline and no changes in color were noted in the tubing nor in the flushed out liquid.No visible damage or defect was observed from returned kit.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.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

Based on further engineering investigation, it was identified that this issue supplier related.Therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Additionally, there are manufacturing controls to avoid potential causes related to the reported malfunction.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: PRESSURE MONITORING SET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15333508
• MDR Text Key: 301493903
• Report Number: 2015691-2022-07644
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: PXMK2041
• Device Catalogue Number: PXMK2041
• Device Lot Number: 64184103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/06/2022; 11/09/2022
• Supplement Dates FDA Received: 10/07/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2024
• 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