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

Model Number PX2X2

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that before use, the disposable pressure transducer tubing disconnected.There was no allegation of patient injury.Patient demographics not were not able to be obtained.The device was available for evaluation.

Manufacturer Narrative

One double disposable pressure transducer (dpt) kit was returned for examination.The reported event of "pressure tubing disconnected" was confirmed as broken.The pressure tubing which was connected to the female connector was broken (not detached) from the cvp dpt zero-stopcock.No other visible damage was observed from the kit.It should be noted that broken tubing is not a reportable event but detached tubing is.In this event the customer stated that the tubing ¿disconnected¿ so worse case scenario was assumed and the complaint was reported for detached tubing.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to determine the root cause and implement any necessary corrective actions.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.Breakage of a connector will most likely occur during handling and manipulation of the product and will result in an obvious leak prior to connecting to the patient or during tightening of connections during use.Therefore, the break in the system will be immediately detected.As a result, the potential for injury of this failure mode is remote.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.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.

Manufacturer Narrative

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

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS
• 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: 7642443
• MDR Text Key: 112568723
• Report Number: 2015691-2018-02478
• 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,Followup
• Report Date: 06/12/2018

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: 08/28/2019
• Device Model Number: PX2X2
• Device Catalogue Number: PX2X2
• Device Lot Number: 61012816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 07/23/2020
• Supplement Dates FDA Received: 07/30/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1