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

Model Number T100214A

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem Air Embolism (1697)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded at the hospital.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.No corrective actions will be taken at this time.Lot number was not provided; therefore, review of the manufacturing records could not be completed.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.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.The ifu states: ¿do not allow air bubbles to enter the setup, especially when monitoring arterial pressures.¿ ¿if all air is not removed from the bag, air may be forced into the patient¿s vascular system when the solution is exhausted.¿ ¿significant distortion of the pressure waveform or air emboli can result from air bubbles in the setup.¿ ¿periodically check fluid path for air bubbles.Ensure that connecting lines and stopcocks remain tightly fitted.¿ air emboli is a stated complication in the ifu.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is unknown whether user or procedural factors played a role in this event.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

It was reported that during use, the tubing of the disposable pressure transducer (dpt) disconnected at the male connector.The dpt was attached to a cvp line.It was indicated that the patient suffered an air embolism while sitting in a chair.Follow up with hospital indicated that after treatment the patient¿s condition was favorable and no other complications were reported.The device was not available for evaluation since it was discarded.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7723108
• MDR Text Key: 115128331
• Report Number: 2015691-2018-03027
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T100214A
• Device Catalogue Number: T100214A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• 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
• Patient Outcome(s): Other