MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; PRESSURE MONITORING KIT

Model Number PXMK10204

Device Problem Contamination (1120)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

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 material was found inside the disposable pressure transducer.It was in the connection between the dpt and iv tubing, in an opened package, before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One single dpt kit with an iv set and pressure tubing were returned for examination.The reported event of unknown material was found inside of the connection between the dpt and iv tubing was confirmed.Although the customer reported that this event occurred before use and upon opening the package, priming solution was found in the tubing and the dpt.Two unknown brown materials were observed, one was inside the dpt fluid path on the female luer side, and the other one was at the connection between the dpt female luer and the iv tubing male connector.The materials were approximately 7 x 0.5 mm (inside of dpt fluid path) and 4 x 0.5mm (at the connection) in size.Leakage was observed from the connection between the dpt female luer and iv tubing male connector during leak test.The materials stayed at the same location after 5 minutes of continuous flushing.The connection between the dpt female luer and iv tubing male connector was disconnected, and the brown materials were removed for further evaluation and analysis.No leakage was observed throughout the kit after removing the brown materials.It appeared that the brown material at the connection had interfered with the tight connection between the luers and created leakage path.A supplemental report will be forthcoming when the chemistry results are received.A review of the manufacturing records indicated that the product met specifications upon release.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 part of this monthly review.

Manufacturer Narrative

The reported event of contamination was confirmed.The found unknown brown material was consistent with that of cellulose.Since the device was supplier related issue, the supplier was notified about the complaint.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.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11388883
• MDR Text Key: 234047618
• Report Number: 2015691-2021-01585
• 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: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2022
• Device Model Number: PXMK10204
• Device Lot Number: NP0566MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1