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

Model Number CK4204VP_

Device Problems Moisture Damage (1405); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

One vamp plus unit with pressure tubing was returned for examination.The reported event of ¿water drops-like material was observed¿ was confirmed.As received, clear liquid like material was observed in the pressure tubing fluid path between the one-way stopcock to z-site.The drawing of the vamp plus sub-assembly instructed that the inside walls of the body and plunger/cap interface are to be lubricated with fluid silicone.The z-site sub-assembly also instructs that the backplate of the z-site to be lubricated with a mixture of isopropyl alcohol and sterile water, and a slit of disk rubber to be lubricated with a mixture of silicone and vertrel.A supplemental will be forthcoming with chemistry results when received.A review of the manufacturing records indicated that the product met specifications upon release.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.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 instance there was no patient involvement.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 water drops-like material was observed within the device when the package was opened.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Chemistry results of the clear liquid that was found inside of the pressure tubing indicated that the ir spectrum showed similar absorption characteristics when comparing to silastic adhesive like material.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A supplemental report will be sent with the investigation results.

Manufacturer Narrative

A preliminary investigation found that if the automated fixture that dispenses the silicone has deteriorated, and the manual operator rotates the plunger to distribute the silicone incorrectly this malfunction could occur.Preventative maintenance was performed to the fixtures as an action to reduce the number of particulates in the vamp plus.Additionally, a personnel acknowledgment was provided to the manufacturing personnel.

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: 9343787
• MDR Text Key: 194631631
• Report Number: 2015691-2019-04297
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2019

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: 07/12/2023
• Device Model Number: CK4204VP_
• Device Lot Number: LC1937MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 12/19/2019; 07/23/2020
• Supplement Dates FDA Received: 12/13/2019; 12/24/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1