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

Model Number PXMK053

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.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 while using this disposable pressure transducer, the tubing was leaking at the distal connection site.A new stopcock was connected to try to troubleshoot but the leak did not stop.The device was exchanged and the problem was solved.It was later confirmed that the leakage was of blood and the patient was a pediatric patient.However, no harm was posed to the patient.

Manufacturer Narrative

One pressure tubing set was returned for evaluation.The reported event of tubing leakage at the distal connection site was not able to be confirmed.As received, connections between 4-way stopcock and pressure tubings were tight.Dry blood was visible inside pressure tubings and attached stopcock, however kit was able to be primed and flushed without any occlusion.No leakage was detected from returned kit.No visible damage or defect was observed from the kit during visual examination.All male and female luers of 4-way stopcock and tubing connectors dimensionally passed iso standards.The allegation of leakage was not able to be confirmed, however, dry blood was visible from the returned kit.Further investigation regarding manufacturing defect is under evaluation.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.

Manufacturer Narrative

It is unknown if any manufacturing or procedural defect was present in the device, since the malfunction could not be replicated.However, 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.

• Brand Name: PHOENIX 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
• MDR Report Key: 13064657
• MDR Text Key: 283509060
• Report Number: 2015691-2021-06991
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

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 Model Number: PXMK053
• Device Catalogue Number: PXMK053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/27/2022; 02/15/2022
• Supplement Dates FDA Received: 02/08/2022; 02/15/2022
• 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