MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR FLOTRAC SENSOR; TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR

Model Number MHD8S

Device Problem Contamination (1120)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text : awaiting product return.

Event Description

It was reported that a foreign material was found inside the tubing before use.No information is available if the package was opened or regarding the details of the foreign material.Patient demographics were requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one flotrac sensor with attached iv and pressure tubing sets and non-ew syringe.The customer report of a foreign material was found inside the tubing was confirmed.An unknown particulate, about 1 mm x 2 mm in size, was found attached to the inner wall of pressure tubing at 10 cm distal from the zero-stop cock.The particulate was partially black and transparent.The particulate was attached to the tubing surface and did not move during 5 minutes of continuous flushing.The materials were sent to chemistry lab for further analysis.Per chemistry result, the sample spectrum was consistent with pvc.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As part of the manufacturing process, current risk mitigations include leak test and 100 percent visual inspection.It was identified that the involved component is manufactured by tekni-plex costa rica (also known as natvar cr) supplier, which component are not processed internally in the dr edwards manufacturing process.In addition, during product evaluation it was confirmed that the particulate was embedded to the inner wall of pressure tubing and the unknown material showed similar absorption characteristics when comparing to pvc; since this component (pvc) is not processed as part of the dr manufacturing, consequently, this is a supplier related condition.The supplier was notified regarding the issue on this component.

• Brand Name: FLOTRAC SENSOR
• Type of Device: TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR
• 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 ; 9492507258
• MDR Report Key: 18741595
• MDR Text Key: 336097861
• Report Number: 2015691-2024-01171
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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