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

Model Number PX260

Device Problems Leak/Splash (1354); 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 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 during use in a patient of a disposable pressure transducer (dpt), a foreign object was found inside the fluid path.There was no allegation of patient injury.The product was available for evaluation.The patient demographics were unavailable.

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of "foreign object was found inside the fluid path" was not confirmed.A visual examination of the kit both before and after decontamination did not find any presence of a foreign substance inside of the kit.Liquid inside of the kit was also flushed out to filter paper for 5 minutes for further examination.There was no visible foreign substance on the filter paper.However, leakage was detected from the dpt flush device housing.Leakage occurred from one crack, 0.20" approximately in length, below the weld area of the flush device housing.No other visible damage or leakage was observed from the dpt kit.A review of the manufacturing records indicated that the product met specifications upon release.Please note that leakage occurring below the weld area through a crack would not be a reportable event.Leakage implies a small amount of fluid loss that is unlikely to result in an injury.This generally results in the need to exchange the device, which can be done with a minor interruption in therapy.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 part of this monthly review.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 9825980
• MDR Text Key: 194509370
• Report Number: 2015691-2020-10935
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62710034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1