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

Model Number PXMK10740

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)

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

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 an unknown white material was found floating inside the pressure tubing, approximately 2cm towards patient side from the dpt, before use.There was no patient involvement.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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 unknown clear material observed inside pressure tubing at approximately 2.0 cm distal from female luer which was connected with dpt was approximately 1 x 1 mm in size.The materials stayed at the same location on pressure tubing after 5 minutes of continuous flushing.Per chemistry study the ir spectrum of the unknown clear material was consistent with that of polycarbonate.The issue was informed to the supplier of the device.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: 12029168
• MDR Text Key: 258382583
• Report Number: 2015691-2021-03680
• 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,Followup
• Report Date: 08/12/2021

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: 02/24/2023
• Device Model Number: PXMK10740
• Device Lot Number: PF0519MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 07/07/2021; 08/05/2021
• Supplement Dates FDA Received: 07/29/2021; 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1