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

Model Number T581203B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

We received one 10cm pressure tubing with an attached stand-alone 4-way stopcock for examination.The reported event of tubing disconnection was confirmed.The returned tubing was 9.3cm in length.The pressure tubing was found broken from the bond joint with the distal tubing male connector.The tubing male connector was not returned.Cross surface of the broken tubing appeared uneven and rough.No other visible damage was observed from returned unit.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The 510k number is unknown as this is a custom defined product.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 broken 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.It is not known if user or procedural factors may have contributed to the 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

During use of a dpt the reporting facility stated that the pressure tubing disconnected from the stopcock as well as stating there was an arterial cannula leakage.The issue was noted as the monitor ceased to display the arterial pressure.The user stated there was "significant blood loss".Further clarification of the event was unable to be obtained as well as patient demographic information.No patient injury reported.

Manufacturer Narrative

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

• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7004868
• MDR Text Key: 92179451
• Report Number: 2015691-2017-03718
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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: T581203B
• Device Catalogue Number: T581203B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 01/03/2018
• 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