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

Model Number PXMK10209

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The device was discarded.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot/serial number was not provided thus a device history record was not reviewed.  it is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.In this case, there were no patient impact.  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 the bonding connection between the dpt and the merit flush device was disconnected then followed by blood leakage, during use.The devices were discarded at the hospital.Although there was blood leakage observed, there were no patient complications reported.Patient demographics are unavailable.

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: 10280455
• MDR Text Key: 199833208
• Report Number: 2015691-2020-12527
• 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
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXMK10209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1