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

Model Number VP3601TSA

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/24/2020

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 and device history results when received.

Event Description

It was reported that an unknown air bubble-like material was observed inside the pressure tubing before use.Occurrence date is unknown.There were no patient complications reported.Patient demographics are not available.

Manufacturer Narrative

One vamp plus unit with pressure tubing was received for evaluation.The reported event of contamination in the pressure tubing was confirmed.As received, clear liquid like material was observed in pressure tubing fluid path between one-way stopcock of vamp plus and z-site.No other visible defect/damage was observed throughout the unit during visual examination.Further analysis of the material is under process.A device history record review was completed and documented that device met all specifications upon distribution.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.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

Additional investigation for the contamination in the pressure tubing confirmed that the sample is a clear liquid-like material, consistent with that of silicone oil.

• 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: 10532866
• MDR Text Key: 206970503
• Report Number: 2015691-2020-13561
• 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
• Report Date: 08/24/2020

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: 05/06/2024
• Device Model Number: VP3601TSA
• Device Lot Number: LU0431MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 10/19/2020
• Supplement Dates FDA Received: 10/08/2020; 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1