MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLO TRAC SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number FLOTRAC UNKNOWN

Device Problem Incorrect Measurement (1383)

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

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be 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 part of this monthly review.

Event Description

As reported, after analysis of a blood gas sample taken by an assistant nurse in the post-op ward from this flotrac with vamp system, the values were significantly different compared with the values obtained with an earlier taken blood sample.A second blood sample was taken from the same assistant nurse, being also the values deviant and considered not relevant.A third blood sample was taken by a flotrac expert and the values obtained after analysis were completely normal and expected.As per customer's opinion, this event was probably caused due to the 2 first samples were taken too fast and destroyed the blood bodies.Customer confirmed there was no product malfunction.There was no allegation of patient injury.The device was not available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

In this case it was reported that the blood gas analysis values obtained from two consecutive blood samples were different from a blood sample taken previously.As per customer's opinion, these two samples were probably aspirated too quickly resulting in the destruction of blood bodies and therefore a user error.The third blood gas sample was taken by a flotrac expert and the values obtained after analysis were completely normal and as expected.In this case a definitive root cause cannot be determined however blood sampling technique likely caused or contributed to this event.There was no allegation or indication of a device malfunction.The ifu recommends that the vamp reservoir be filled over 3-5 seconds.Other things that could affect the abg result include microbubbles, too much heparin, and clotting/hemolysis enroute to the abg analyzer.

• Brand Name: FLO TRAC 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17668652
• MDR Text Key: 322483768
• Report Number: 2015691-2023-15654
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOTRAC UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• 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