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

Model Number PX212

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Edema (1820)

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of "fast drip" was confirmed.After priming, a visible flow of water was noticed through the dpt housing without activating the flush device.Red dye solution was injected through the dpt housing without activating the flush device to trace the flow path.The red dye solution bypassed the flow restrictor and traveled to the fast-flush fluid path of the dpt housing.An unknown particulate was found stuck between the poppet and flush device housing.The particulate was hard, curly and approximately 0.2" in length.The particulate prevented the blue poppet from closing off the fast-flush fluid path and created an unrestricted flow thru dpt housing.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A supplemental report will be forthcoming with the chemistry results once received.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to use the system, to consider the potential benefits in relation to the possible complications.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Incorrect flow rates that result in significant unintended fluid delivery poses a risk to the patient.In this case there was right hand and arm edema but no other injury noted.The right arterial line was not discontinued.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.

Event Description

It was reported that the rn observed that the pressurized fluid bag to the arterial line was ¿empty¿.The right radial arterial line was placed 12 hours prior.In addition, it was noted that the right hand and arm were edematous and there was ¿a continuous fast drip from the arterial pressure bag¿.The arterial line itself was not removed but the arterial pressure bag, fluid bag, and tubing/transducer to the arterial line were changed out.It is unknown how much fluid was infused over the 12-hour period.The physician was notified.The right arm was monitored and a good waveform for the art line was noted and blood return was still present so the arterial line was not discontinued.No immediate harm was noted to the patient.The patient denied pain, numbness or tingling.Inquired of patient demographics.Unable to be obtained.

Manufacturer Narrative

An investigation found that the origin of the nylon like material could not be found in edwards manufacturing plant.An investigation was also conducted at the supplier for the dpt housing assembly.Possible sources of contamination were analyzed.No definitive root cause for the nylon particle was able to be determined from the manufacturing process.

Manufacturer Narrative

Reference capa-(b)(4).

Manufacturer Narrative

The chemistry results indicated that the ir spectrum of the unknown material found in the dpt housing showed similar absorption characteristics when comparing to nylon like material.An investigation is underway to ascertain if nylon like material is found in any part of the manufacturing process.

• 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: 7540507
• MDR Text Key: 109232056
• Report Number: 2015691-2018-01976
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX212
• Device Catalogue Number: PX212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/24/2018; 07/30/2018; 07/23/2020
• Supplement Dates FDA Received: 06/19/2018; 08/01/2018; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other