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

Model Number VO3313TSPL03

Device Problems Contamination /Decontamination Problem (2895); 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 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that a rubber-like piece was found inside of a vamp flex reservoir during use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One dpt-vamp flex kit with iv set and pressure tubing were returned for examination.The reported event of contamination issue inside of the vamp flex was confirmed.One black material was observed inside of the vamp flex reservoir during a visual examination.The material was approximately 0.5mm x 0.5mm in size.The plunger of the vamp flex was pushed to a closed position and liquid observed in vamp flex reservoir was pushed into the pressure line, but the particulate stayed at the same location inside of the vamp flex reservoir.The vamp flex was shut-off using the reservoir stopcock, and the whole line was flushed continuously for 5 minutes, but no visible particulate was flushed out from the kit.The vamp flex reservoir was cut, and the material appeared to be stuck on inner wall of the reservoir.Chemistry results indicated that the ir spectrum of the unknown black material cannot be identified because of low absorbance energy.Eds detected the following: silicon, sodium, magnesium, calcium, aluminum.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.The noted particulate was not able to be flushed out during 5 minutes of continuous flushing.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

Investigation found that the potential root cause for this nonconformance could be a supplier material defect.As this defect cannot be generated at our manufacturing process, a supplier notification was made to their personnel about the condition.

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: 9282527
• MDR Text Key: 194925059
• Report Number: 2015691-2019-04107
• 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: 10/18/2019

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 Model Number: VO3313TSPL03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 01/03/2020; 07/23/2020
• Supplement Dates FDA Received: 12/15/2019; 01/10/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1