MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

One disposable pressure transducer (dpt) was received by our product evaluation laboratory for a full evaluation.The reported event of particle found inside the pressure tube was confirmed.One unknown dark brown particulate, approximately 68 cm proximal from pressure line distal tip, was observed inside pressure tubing.The particulate, approximately 0.1" x 0.08" in size, attached to the inner wall of pressure tubing.The particulate stayed at the same location on pressure tubing after 5 minutes of continuous flushing.Pressure tubing was cut and the particulate was sent to chemistry laboratory for further analysis.Infrared (ir) spectrum of the unknown material showed similar absorption characteristics when comparing to poly(vinyl chloride), pvc, like material.The exact lot number for the involved device was unknown.However, the following suspected lot numbers were provided: 63826292, 63879686, 63812833, 63778849, 63723457.The manufacturing records will be reviewed for the suspected lot numbers.An engineering investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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, before use in patient with this pressure monitoring set, a foreign object was found inside the line tubing.It was planned to be used for patient arterial blood pressure (abp) measurement.This foreign object is in a state of movement; therefore, it was not embedded and it moves along with the fluid flow.There were no other abnormalities on both sides, and the exterior condition was clean.There was no allegation of patient injury.Patient demographics were requested, but not yet provided.The device was available for evaluation.

Manufacturer Narrative

Patient demographics could not be obtained.The manufacturing records were reviewed for the suspected lots involved and there is no indication of a related nonconformance.All process parameters were met, and inspections passed successfully.Based on further engineering investigation, a capa and a product risk assessment were generated.Based on all the identified facts, the reported condition was considered a supplier related issue.The corresponding supplier notification was properly sent in order to eliminate the cause of the non-conformity and prevent recurrence of this type of complaint.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: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 12867419
• MDR Text Key: 283257958
• Report Number: 2015691-2021-06497
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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: PX260
• Device Catalogue Number: PX260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1