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

Model Number PXVP2260

Device Problems Material Separation (1562); Failure to Zero (1683); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as per initial reporter's policy of not returning devices.However, one picture was provided and reviewed.The reported event of detachment was confirmed.The image showed the male connector of an iv set and a dpt sensor housing.The iv set connector was separated from the dpt housing female connection.No visible inconsistencies were noticed from the iv male connector or from the rest of the unit. a device history record review was completed and documented that device met all specifications upon distribution.Additional investigation for manufacturing non conformances has been initiated and will be reported, if confirmed.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.

Event Description

It was reported that when connecting this pressure monitoring set with vamp to the saline bag, it was observed that the transducer was separate and it was contaminated when touching the surface.There was no allegation of patient injury reported.The device was not available for evaluation.  it was later updated that the problem was in the side of the zeroing stopcock.The connector was separated from the tubing.The tubing was intact.It was confirmed the event occurred before use in patient.The device was not available for evaluation as per reporter's policy of not returning devices with suspicion of failure that were in the patient's environment.

Manufacturer Narrative

The device did not return thus, the malfunction location could not be confirmed.  according preliminary investigation of the reported condition the most likely causes may be:  leakage at the joint between tubing to connector bond.Partial occlusion.Not enough fluid flow thru the iv line.Product replacement required. crazing of tubing, fluid leakage during procedure.Tubing breakage or detachment when handled, pulled or bend, resulting in disconnection.Based on all this we conclude that this malfunction could not be confirmed that condition is generated as part of the manufacturing process.Consequently, no further actions under this complaint are deemed necessary.However, the condition will continue being monitored through the complaint system for further occurrence.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

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 10149913
• MDR Text Key: 195933251
• Report Number: 2015691-2020-12157
• 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
• Report Date: 05/15/2020

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 Expiration Date: 09/09/2021
• Device Model Number: PXVP2260
• Device Catalogue Number: PXVP2260
• Device Lot Number: 62538060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 07/23/2020
• Supplement Dates FDA Received: 07/10/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 60