MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER KIT

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 04/30/2021

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 however, a device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that before use in patient with this disposable pressure transducer (dpt), a dark particulate was note inside the pressure tubing.There was no allegation of patient injury.

Manufacturer Narrative

The reported event of contamination was confirmed.The pressure line was flushed continuously for 5 minutes.The unknown material was not flushed out from the pressure line during flushing.The spectrum of the unknown material showed similar absorption characteristics as of pvc colorite.The particle resulted to be pvc colorite according to the chemical evaluation which means that this material is part of the same tube which could get there during the extrusion process, therefore, the supplier was formally notified.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.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER KIT
• Type of Device: DISPOSABLE PRESSURE TRANSDUCER KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11900975
• MDR Text Key: 253196040
• Report Number: 2015691-2021-03203
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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: No Information
• Device Expiration Date: 07/23/2022
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 63276139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1