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

Model Number PX272

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

One dpt pressure tubing was received for evaluation.The reported event of foreign object found in the tubing was confirmed.An unknown dark particulate, about 5mm in length, was found attached to the inner wall of distal pressure tubing at 60 cm from the female connector.The pressure tubing was flushed continuously for 5 minutes but the unknown material stayed inside during the continuous flushing.No other particulates found on filter paper.The findings were aligned to the provided image by the customer.The material is sent for further analysis.A device history record review was completed and documented that device met all specifications upon distribution.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 right after opening the package of this disposable pressure transducer, there was contamination in the extension tube.There is no patient involvement.The product was available for evaluation.

Manufacturer Narrative

Based in the result of this complaint investigation, the main cause for the dark particle is pvc material found inside the high pressure tubing.This type of material is the same as the high pressure tubing; therefore, the root cause was attributed to defective material from the supplier.The supplier was notified of the evaluation.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

Additional investigation concluded that ir spectrum of the unknown dark material and pressure tubing both showed similar absorption characteristics of a pvc like material and it is part of the manufacturing process.

• 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: 10370971
• MDR Text Key: 204781386
• Report Number: 2015691-2020-12949
• 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,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: PX272
• Device Catalogue Number: PX272
• Device Lot Number: 62983950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1