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

Model Number MHD6S

Device Problem Contamination (1120)

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

Event Date 02/05/2024

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.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 iv tubing before use.It appeared to be a floating material, but the details were not known.The package was opened.Patient demographics were requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one flotrac sensor with attached pressure tubing set and detached iv set.The customer report of a foreign material was found inside the iv tubing was confirmed.An unknown black material less than 0.5 mm x 0.5mm in size, was found in the iv tubing at 8.4 cm from the distal end of the iv set.Another unknown black material less than 0.5 mm x 0.5mm in size was found in the drip chamber.The materials did not move during 5 minutes of continuous flushing.After cutting out around the material area, it was confirmed that the materials were embedded inside the iv tubing wall and the drip chamber wall.The materials were sent to chemistry lab for further analysis.Regarding a black material embedded in the pressure tubing wall, the spectrum did not have a good match with anything in edwards library.Regarding a black material embedded in the drip chamber wall, it was too small to isolate it from the drip chamber wall.Therefore, it was unable to test.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.There are manufacturing controls to avoid potential causes related to the malfunction of - iv tubing and catheter body contamination embedded in the components which are incoming sampling inspection, 100 percent visual inspection, manufacturing continuous monitoring sampling, and qa sampling inspection.As part of the execution of the engineering evaluation process, the inspection and specification criteria by type of contamination indicates that for embedded particles for a size of less than 0.05 mm2 and the maximum number of particles per 100 cm2, is unlimited.Since this size of embedded particle is accepted, it is not considered as a manufacturing defect.Product risk assessment and capa escalation were not required.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18741648
• MDR Text Key: 336090157
• Report Number: 2015691-2024-01172
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/20/2024

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: MHD6S
• Device Lot Number: 65330512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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