MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE

Model Number T001657A

Device Problems Complete Blockage (1094); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during the preparation of this pressure monitoring set, the arterial line was occluded.It was impossible to unclog manually by flushing the device with the blue snap tab.Therefore, it required the usage of a 2 ml syringe to unclog the device applying force.There was no allegation of patient injury.Patient demographics were requested but not available.Follow up has started for device return.

Manufacturer Narrative

Additional information were provided.Flushing this pressure monitoring set was still very difficult despite using a 2ml syringe.Therefore, the pressure sensor and the patient's red line were changed by new ones from another kit.No patient has been in contact with this system.Event date was added in b3.On the other hand, the pressure monitoring set involved in this case was received by our product evaluation laboratory for a full evaluation.The reported event of occlusion was confirmed.Flow restriction was detected from the kit during priming and flushing.Occlusion was found at bond joint between pressure tubing and female connector which was connected to zero stopcock.Bonding material formed a blockage inside pressure tubing and restricted the flow during priming.Drawings for model t001657a instructed to bond pressure tubing with the connector with bonding solvent.The flush device of the kit functioned properly.No other visible damage was observed from the kit.The risk assessment has been updated based on product evaluation results.Difficulty flushing/priming may have several root causes, but the end result would be an inability to flush the device during setup or inability to obtain blood pressure readings during use.The users of the device are well trained to trouble shoot, and if required, the device can be exchanged with minimal delay in monitoring/treatment.Therefore, potential for death or serious injury is remote.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE
• 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: 15127968
• MDR Text Key: 302058960
• Report Number: 2015691-2022-07066
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001657A
• Device Catalogue Number: T001657A
• Device Lot Number: 64202506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• 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