MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUCLIP; STAND, INFUSION

Model Number TRUCLIP

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded at the hospital.Without return of the product, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Lot number was not provided; therefore review of the manufacturing records could not be completed.The truclip is designed to keep the pressure transducer at the phlebostatic axis for accurate pressure readings.In the event that the truclip is broken and does not remain stationary on the iv pole, it is possible to receive inaccurate pressure values.Pressure readings should correlate with the patient¿s clinical manifestations.The truclip ifu includes a warning that states: ¿truclip must be mounted securely to ensure clinical stability and to prevent injury to the patient or user¿.The ifu also advises the clinician to clean the surface of the truclip before and after each use by wiping with 70% isopropyl alcohol or 5% bleach and inspect to ensure the integrity of the device.It is common clinical practice for the clinician to monitor the transducer vent port so that it corresponds to the chamber where the pressure is being measured.Clinicians routinely follow hospital policies and procedures for frequency of zeroing the transducer system and thereby monitoring the level of the truclip device.In this case the patient was treated on inaccurate values but no patient compromise was 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.This is 510k exempt as this is a class 1 device.

Event Description

It was reported that during use in the icu, the blue grip pads of truclip came off from the clip.Later during the procedure the clinician found that the cvp and arterial pressure value were high and bloodletting was performed.At this time, it was noticed that the truclip had slid down from the pole and consequently was in the correct position to get accurate values.There were no patient complications reported.Patient demographics were unable to be obtained.The device was discarded by the hospital.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: TRUCLIP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 7927344
• MDR Text Key: 123207707
• Report Number: 2015691-2018-04007
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRUCLIP
• 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