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

Model Number PX260

Device Problems Detachment Of Device Component (1104); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

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 prior to use of a disposable pressure transducer, the tubing female connector was disconnected when the nurse opened the package.The customer photograph of the product indicates that the tubing was detached.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Reference capa (b)(4).

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of "tubing female connector was disconnected" was confirmed.The tubing had detached from the bond joint with a female connector.The location of the detachment appeared consistent with the customer photo.The tubing end appeared smooth and even and was found bent near the point of detachment.Indications of bonding solvent were evident on some locations of tubing bond surface area.The tubing outer diameter was measured near the point of detachment and was found to be within specification.The detached tubing female connector was not returned.No other visible damage or defect was observed from the kit.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.It is common clinical practice to inspect all products before usage.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.In this event, there was no patient compromise 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.

Manufacturer Narrative

The investigation concluded that the most probable root cause is related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

• 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: 7545325
• MDR Text Key: 109632850
• Report Number: 2015691-2018-02002
• 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,Followup
• Report Date: 05/02/2018

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: 11/28/2019
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 61175992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 07/11/2018; 07/23/2020
• Supplement Dates FDA Received: 07/02/2018; 07/23/2018; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 66