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

Model Number MHD8

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The hospital discarded the unit.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.In this case, there was blood loss.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 during cardiopulmonary bypass assisted cardiac surgery on a patient with this flotrac sensor, blood leakage was found around the left radial artery punctured area after the surgical drape was removed.There was also blood infiltration around the drape, the bleeding volume was approx.100-150 ml.After examined, there was blood oozing slowly at the connection between the arterial puncture needle and the flotrac.The customer tried to tighten the connection site but still could observe blood oozing out.A new sensor was replaced and confirmed that there was no more blood oozing out.Disinfection was carried out before fixing the new device to the patient.In addition, there was no medication loss reported.After the operation, the patient received 2u rbc(red blood cell) and 370ml of plasma transfusion in the icu.After the blood transfusion, there was no other allegation of patient injury.The device was not available for evaluation, since it was discarded at hospital.Patient demographics are not available.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.

• 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
• MDR Report Key: 10461255
• MDR Text Key: 204875644
• Report Number: 2015691-2020-13318
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: MHD8
• Device Catalogue Number: MHD8
• Device Lot Number: 62500235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention