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

Model Number PX3X3

Device Problems Detachment Of Device Component (1104); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

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 results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

As reported, the disposable pressure transducer was noted to be separated on the pressure tubing side of the dpt system.This was found before use.There were no allegations of patient injury.No patient demographics available.

Manufacturer Narrative

One triple dpt kit was returned for examination.The reported event of "arterial line separated" was confirmed.The pressure tubing which was connected to the female connector of the arterial pressure line was detached from the solvent bond joint.Bonding solvent was visible on the tubing and a the female connector at the bond area.Damage was also found at the iv tubing male connector.The tube adapter, where the iv tube was bonded to the male connector broke from the male connector at the end of the iv line.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.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.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.In this event, there was no patient compromise noted as the issue was discovered before use.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

The investigation concluded that the most probable root cause is related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS
• 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
• MDR Report Key: 7488935
• MDR Text Key: 107508085
• Report Number: 2015691-2018-01691
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2018

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: PX3X3
• Device Catalogue Number: PX3X3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 07/03/2018; 07/23/2020
• Supplement Dates FDA Received: 06/12/2018; 07/12/2018; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1