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

Model Number PXVPP11212

Device Problem Contamination (1120)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a small shiny foreign material was found inside the tubing about 3 cm from the one way stopcock of vamp plus before use.A nurse marked the location with a marker pen.The device was replaced, and the problem was solved.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported event of small shiny foreign material was found inside the tubing about 3 cm from the one way stopcock of vamp plus was confirmed.One clear spot or material was observed in pressure tubing flow path at approximately 32mm distal from one way stopcock of vamp plus unit during visual examination.The clear spot or material was approximately 1 mm x 1 mm in size.Pre deco evaluation stated that 2 black substances were observed, but it was confirmed during product evaluation that they were not substances but ink of black marker as stated in description of event that nurse marked the location with a maker pen.The kit was flushed continuously for 5 minutes, but the clear spot or material stayed at the same location inside pressure tubing after 5 minutes of continuous flushing.No other visible particulates were flushed out from the kit.Further evaluation regarding related quality issues is under investigation.The device history record review for lot xs1194mt was completed by a third party to check the third party assembly process.It was documented that the device met all specifications upon distribution.Lot was manufactured on october 2022 and expires on 26october2024.An additional device history record review will be completed for the edwards component lot.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

Device was sent to chemistry lab for further analysis.It was reported that the pressure tubing was cut at the indicated mark, but no sample was found.Sample may have migrated during transport.No match was performed.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

A device history record review on the edwards component lot was completed.It was documented that the device met all specifications upon distribution.Engineering evaluation was completed.Updates to the h6 codes are as follows investigation findings was changed to inappropriate material and investigation conclusions was changed to cause traced to manufacturing.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: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16897171
• MDR Text Key: 314898015
• Report Number: 2015691-2023-12881
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2023

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 Model Number: PXVPP11212
• Device Lot Number: XS1194MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/12/2023; 06/20/2023; 07/10/2023
• Supplement Dates FDA Received: 05/31/2023; 07/06/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1