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

Model Number VO1206TTPL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

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, however the lot/serial number was not provided thus a device history record cannot be reviewed.

Event Description

It was reported that the connection between the pressure tubing on the yellow line and the female connector of a disposable pressure transducer was found detached in the icu after surgery.The customer was aware of the event and immediately performed reconnection.The patient sex: male, initial: n, other demographic information requested but unavailable.Although there was blood leakage observed, there were no patient complications reported.Amount of blood loss is unknown and unable to obtained at this time.

Manufacturer Narrative

One single pressure tubing with attached male connector and one three-way stopcock attached to female connector was received for evaluation.The reported event of detached connection issue was confirmed.As received, pressure tubing was detached from the female connector.Residual solvent was observed on inserted portion of the detached tubing.Further investigation is under evaluation.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.In addition, they are used in critical care units or ors where patients are closely monitored.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.In this case, there were no patient impact.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

The manufactures investigation found that the supplied tube outer diameter is close to the minimum specification which has the potential to affect the strength of the bonding material.In addition, a potential root cause could be related to an incorrect solvent bonding execution during the assembly process.

• Brand Name: PRESSURE MONITORING KIT CUSTOM
• 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
• MDR Report Key: 11270370
• MDR Text Key: 232859445
• Report Number: 2015691-2021-01024
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VO1206TTPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1