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

Model Number T001670A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2018

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 as the patient was transferred to a bed, the pressure tubing of this disposable pressure transducer with vamp got caught under the patient.Due to the stress put on the tubing, it disconnected.It is unknown at this time if there was any blood loss or patient complications.However, attempts have been made to ascertain the information with the hospital.Any additional information will be submitted in a follow up report.The disposable pressure transducer was available for evaluation.Patient demographics unable to be obtained at this time.

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.

Manufacturer Narrative

One single dpt - vamp adult kit was returned for examination.The reported event of pressure tubing disconnected was confirmed.The tubing had detached from the bond joint with a vamp reservoir stopcock.Indications of bonding solvent was evident on locations of the tubing bond surface area.The tubing outer diameter was measured near the point of detachment and was found to be within specification.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.61121660 manufactured date:11/14/2017 expiration date:11/14/2019.61231767 manufactured date:02/09/2018 expiration date:02/09/2020.

Manufacturer Narrative

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

• Brand Name: 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: 7573389
• MDR Text Key: 110588959
• Report Number: 2015691-2018-02133
• Device Sequence Number: 1
• Product Code: DXO
• 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,Followup,Followup
• Report Date: 05/14/2018

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 Model Number: T001670A
• Device Lot Number: 61121660 OR 61231767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 08/10/2018; 07/23/2020
• Supplement Dates FDA Received: 07/21/2018; 08/10/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1