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 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that after opening the packaging and before use with patient of this disposable pressure transducer, contamination was noted inside the pressure tubing.There was no allegation of patient injury.Patient demographics are not available.

Manufacturer Narrative

One pressure tubing with female luer connected to male connector of this dpt was received for evaluation.The reported event of contamination was confirmed.An unknown dark particulate, about 1mm in length, was found attached to the inner wall of pressure tubing at 6 cm from the female connector.The pressure line was flushed continuously for 5 minutes.The unknown material was flushed out from the pressure line during flushing, and captured on filter paper.After further analysis of the material, it was concluded that the ir spectrum of unknown material showed similar absorption characteristics of a pvc like material.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.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.

Manufacturer Narrative

The reported event of contamination in the pressure tubing was confirmed.This condition is supplier process related and the supplier was notified.No further actions required right now.

• 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: 10532862
• MDR Text Key: 206976680
• Report Number: 2015691-2020-13560
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

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 Expiration Date: 01/16/2022
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62798910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/17/2020; 10/29/2020
• Supplement Dates FDA Received: 10/08/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1