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

Model Number PX260

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit was received for evaluation.The reported event of iv tubing broken was not confirmed.As received all connections were tight and secure.However, an unknown dark particulate, about 5mm in length, was found attached to the inner wall of distal pressure tubing at 116 cm from sensor.Unit was flushed continuously for 5 minutes.The unknown material stayed inside the pressure tubing during 5 minutes of continuous flushing.No other particulates found on filter paper.No leakage was detected from the kit during leak test.No other visible defect was observed from the kit.Further analysis confirmed that the unknown dark material and pressure tubing sample showed similar absorption characteristics when comparing to pvc like material.The lot number was not provided thus a device history record was not reviewed.Further analysis of manufacturing related non-conformances is under evaluation.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.The noted particulate was not able to be flushed out during 5 minutes of continuous flushing.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 a part of the monthly review.

Event Description

It was reported that after opening the packaging and before use with patient of this disposable pressure transducer, the iv tubing broke.There was no allegation of patient injury.The product was available for evaluation.Patient demographics are not available.

Manufacturer Narrative

The reported event of contamination in the stopcock luer was confirmed.The issue was supplier process related and the supplier was notified.

• Brand Name: PRESSURE MONITORING KIT WITH 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 ; DR
• MDR Report Key: 10532870
• MDR Text Key: 206980311
• Report Number: 2015691-2020-13562
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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: 08/26/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1