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

Model Number TCLIP05

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

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; 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.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.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.There is a caution in the ifu instructing the user not to sterilize the truclip.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 facility did not follow edwards instructions to not sterilize.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 a 510k exempt as this is a class 1 device.Medwatch report number mw5081036.

Event Description

It was reported while measuring the patient¿s blood pressure, unknown to the nurse, the arterial blood pressure transducer had fallen off the clip and the blood pressure readings were falsely elevated and the medication was decreased based on the incorrect readings.After the event, inspection of the equipment found that the holders were warping due to the sterilization process.(sterilization is not recommended by manufacturer.) patient demographics unable to be obtained.Follow up attempts have been made for the patient¿s condition.The device was discarded at 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: 8151775
• MDR Text Key: 130659460
• Report Number: 2015691-2018-05206
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TCLIP05
• 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
• Patient Outcome(s): Other