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

Model Number PXVMP160

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Reflux within Device (1522)

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

Event Date 05/20/2018

Event Type  malfunction  

Manufacturer Narrative

One single dpt - vamp adult kit was returned for examination.The reported event of "vamp device failure refluxing blood from central line" was not able to be verified due to a complete blockage of blood inside of the kit.The reported event of "leaking out the pullback device boot" was confirmed.Dry blood was evident on the plunger side of the blue seal and on the inside of the contamination shield.Blood was evident between the seal and reservoir.It was apparent that the blood had leaked past the blue seal to the plunger side and out of the reservoir cap into the contamination shield.The simulated use test to recreate how blood had passed the seal into the plunger side could not be performed due to the occlusion of blood.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.The vamp blood sampling system is used to obtain blood samples through a closed system.Leakage past the plunger seal can be due to a manufacturing non-conformance or user technique.There is potential for air to be drawn into the system and injected into the patient, which could result in an air embolus.Blood or air past the plunger seal would be immediately noted by the user and the blood draw would be stopped.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.In this instance, given the condition of the returned product, it is unknown if this was a manufacturing issue or if user or procedural factors played a role in this 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 a part of the monthly review.(b)(4).

Event Description

It was reported by the clinician that that the vamp device had a reflux of blood from the central venous pressure line and that it was leaking.The device was replaced by the clinician and the problem was solved.No patient complications or blood loss was reported.

Manufacturer Narrative

The investigation concluded that the most probable root cause of blood leaking past the plunger seal is related to an incorrect lack of solvent in the seal or the malposition of the seal in the plunger executed during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

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: 7683988
• MDR Text Key: 114428490
• Report Number: 2015691-2018-02793
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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 Expiration Date: 12/20/2019
• Device Model Number: PXVMP160
• Device Catalogue Number: PXVMP160
• Device Lot Number: 61171690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 07/23/2020
• Supplement Dates FDA Received: 08/17/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 100