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

Model Number PX600I

Device Problems Break (1069); Crack (1135); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

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.A review of the manufacturing records indicated that the product met specifications upon release.Upon further investigation with hospital risk management it was discovered that the integra evd device does not allow for secure fixture to an iv pole.There is nothing to give good support.Therefore the device "jiggles".Because the device jiggles and given the weight of the device, the clinicians are concerned that the evd device will disconnect from the dpt.Consequently the nurses over tighten the dpt device and crack it potentially leading to leakage or a broken connector.The risk manager reiterated that there have been no patient injuries or complications.The potential risk to the patient is loss of cerebral spinal fluid or infection.The nurses have been instructed accordingly regarding the use of the dpt and the hospital is working with the integra rep to resolve the "jiggling" issue.In addition, the nurse manager in this case stated that ¿the investigation has been completed and there is no reason for an edwards representative to visit the facility.¿ they consider the matter resolved.It is noted in the dpt ifu: over-tightened connections may result in cracks or leaks.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.Udi #: ((b)(4).Medsun report number (b)(4).

Event Description

It was reported that when the patient was transported for a ct scan, the pressure cable detached from the external ventricular drain transducer.Cerebrospinal fluid leakage was observed from the transducer that connects to the evd.The plastic was cracked and partially broken.No patient complications were reported.

Manufacturer Narrative

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

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH STOPCOCKS
• 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: 8153347
• MDR Text Key: 130331206
• Report Number: 2015691-2018-05211
• 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
• 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 Expiration Date: 07/31/2019
• Device Model Number: PX600I
• Device Catalogue Number: PX600I
• Device Lot Number: 60975581
• 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