MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT

Model Number VO0101TSPL

Device Problem Contamination (1120)

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

Event Date 03/24/2021

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 and device history results when received.

Event Description

It was reported that before use of this disposable pressure transducer, an unknown cotton-like material was found inside the pressure tubing in an opened pouch.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One single dpt kit with iv set and pressure tubing was returned for evaluation.The pressure tubing remained coiled with paper band.Solution was visible in the kit.The reported event of contamination issue inside the pressure tubing was confirmed.One unknown white material was observed inside pressure tubing near male connector.The material was approximately 2 x 2 mm in size.The materials stayed at the same location on pressure tubing after 5 minutes of continuous flushing.Pressure tubing was cut and the white material was sent for additional 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.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11679423
• MDR Text Key: 247996558
• Report Number: 2015691-2021-02503
• 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: 05/27/2021

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: 11/01/2022
• Device Model Number: VO0101TSPL
• Device Lot Number: NT0096MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1