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

Model Number PX260

Device Problems Difficult to Flush (1251); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt sensor was returned for examination.The reported event of flushing difficulty was not confirmed.As received unknown clear particulates were found in the zero-stopcock male luer.The particulates did not maintain attached to the luer surface and flushed out.The unknown material will be sent to chemistry lab for further analysis.The unit was able to prime throughout the housing without indication of occlusion or flow restriction.The flush device functioned properly.No visible defect was observed from the flush device.There were no other visible indications of occlusion or restrictions on the returned unit.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A supplemental report will be forthcoming with the chemistry and device history results when received.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.In this event, there was no patient compromise noted.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.

Event Description

It was reported that before use in a patient using a disposable pressure transducer, they had difficulties flushing the catheter line.A new product was used and worked successfully.There was no allegation of patient injury.The product was available for evaluation.Patient demographics available.

Manufacturer Narrative

Chemistry results of the unknown material found in the zero-stopcock male luer indicated that the ir spectrum showed similar absorption characteristics when comparing to sodium and chloride.Saline is a commonly used solution used in hospital settings and procedures.This is no longer considered a reportable event.

Manufacturer Narrative

Corrected data: f10, h6.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: 9712288
• MDR Text Key: 196072280
• Report Number: 2015691-2020-10529
• 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: 01/13/2020

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 Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62544734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 02/21/2020; 07/23/2020
• Supplement Dates FDA Received: 02/27/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 65