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

Model Number VP4304TSA03

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

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

Event Date 05/07/2020

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 in this disposable transducer, an unknown water-like liquid was observed inside the pressure tubing in an opened package, before use.It was also reported that the drip chamber seemed to be deformed.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Additional investigation concluded that the spectrum found in the tubing was of clear liquid-like material and consistent with that of polydimethylsiloxane/silicone.This material is part of the manufacturing process.

Manufacturer Narrative

One single dpt-vamp plus kit with iv set and pressure tubing was received for evaluation.No priming solution was visible throughout the kit.Both iv and pressure tubing remained with paper band.The reported event of ¿water-like liquid was observed inside the line¿ was confirmed.As received, clear liquid like material was observed in the pressure tubing fluid path between one-way stopcock of vamp plus to approximately 12cm distal from the stopcock.This was the same condition as shown on photos provided by customer.Drawing 500474 rev.P of vamp plus sub-assembly instructed that inside walls of body and plunger/cap interface to be lubricated with fluid silicone.The sample has been sent for further investigation.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

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: 10097688
• MDR Text Key: 193103958
• Report Number: 2015691-2020-11983
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VP4304TSA03
• Device Lot Number: LT1171MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1