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

Model Number PX2X2

Device Problem Material Separation (1562)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

As reported, after opening the package, before use in patient with this disposable pressure transducer, the tubing was detached.The device was replaced with new unit.No further information was available.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Patient demographics unable to be obtained.The product is returned for analysis; however, it has not been evaluated yet.Upon the evaluation 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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Update: h3 (device evaluated by manufacturer).The device was sent to our product evaluation laboratory for a full evaluation.As received, the iv tube adapter, where iv tube was bonded to the male connector, was completely broken from the male connector.The broken part of adapter remained inside of iv tube.Cross surfaces of broken adaptor appeared uneven and rough.No other visible damage or leakage was observed from the kit.As per product evaluation findings, the failure was related to an iv tubing breakage and not to a tubing detachment as originally reported.As such, this case no longer meets the criteria for reporting.Leakage may occur for several root causes such as small cracks or connections not secured.It implies a small amount of blood/fluid loss that is unlikely to result in an injury.This generally results in the need to exchange the device, which can be done with a minor delay in treatment or monitoring.Therefore, this event is no longer considered reportable and this update is being submitted.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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
• 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: 18758531
• MDR Text Key: 336096727
• Report Number: 2015691-2024-01214
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX2X2
• Device Lot Number: 64818077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/14/2024
• 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