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

Model Number VO3509TSPL

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/12/2020

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 unknown black material was found inside of the tubing before use.It is unknown whether the material was inside the iv tubing or pressure tubing.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

Investigation found that the potential root cause for this non-conformance could be a supplier related material.A supplier notification was made to tekni-plex the manufacturer about this finding.

Manufacturer Narrative

Our lab received the suspect pressure monitoring kit.The reported issue of contamination was confirmed.Brown material was observed inside pressure tubing, on the inner tubing wall at approximately 71cm distal from dpt zero-stopcock.The brown material was approximately 2mm x 0.5mm in size.The material stayed at the same location inside pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and a section of the material was found embedded within the inner tubing wall.The material was sent to irvine chemistry for further analysis.A supplemental report will be forthcoming with the evaluation from the chemistry lab.With pressure tubing sets, it is common for the clinician to check for air or particulates while priming the line for use.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 part of this monthly review.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.The ir spectrum of the brown material noted in the pressure tubing found before use showed a similar absorption characteristic when comparing to pvc like material.

Manufacturer Narrative

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: 9764899
• MDR Text Key: 194127733
• Report Number: 2015691-2020-10712
• 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,Followup
• Report Date: 02/12/2020

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: 06/10/2023
• Device Model Number: VO3509TSPL
• Device Lot Number: LC2004MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/12/2020; 03/30/2020; 04/21/2020; 07/23/2020
• Supplement Dates FDA Received: 03/20/2020; 04/13/2020; 05/07/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1