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

Model Number PX272

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded at the hospital.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.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.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.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.It is unknown whether user or procedural factors played a role in this event.In this event, there was no patient injury 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 part of this monthly review.(b)(4).

Event Description

It was reported that when a patient was being transported from the or to the icu, the tubing on the disposable pressure transducer (dpt) detached from the stopcock.This caused blood to back up into the line and leak.The amount of blood leakage is unknown.The anesthesiologist removed the dpt line and re-placed it with a new line.The device was not saved for examination.No patient complications reported.Inquired of patient demographics.Unable to be obtained.

Manufacturer Narrative

Correction: further follow up with hospital indicated that the pressure tubing did not detach but rather the top of the stopcock broke off of the disposable pressure transducer kit.This caused blood to back up into the line and leak out of the top of the stopcock.The amount of blood leakage is unknown.The anesthesiologist removed the dpt line and re-placed it with a new line.The device was not saved for examination.No patient complications reported.Inquired of patient demographics.Unable to be obtained.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.The top of a stopcock breaking off has the potential to result in large amounts of fluid/blood loss.If the stopcock breaks off during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.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.It is unknown whether user or procedural factors played a role in this event.In this event, there was no patient injury noted.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• 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: 7782648
• MDR Text Key: 117272903
• Report Number: 2015691-2018-03360
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2018

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 Expiration Date: 04/05/2020
• Device Model Number: PX272
• Device Catalogue Number: PX272
• Device Lot Number: 61307956
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 07/23/2020
• Supplement Dates FDA Received: 09/06/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1