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

Model Number T001670A

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

One vamp adult was returned for examination.The reported event of tubing issue was confirmed.The tubing detached from the bond joint of the vamp reservoir connector.There is a small amount of bonding materials in the tubing area and the reservoir connector.The tubing outer diameter near the point of detachment was measured and found to be within specification.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Lot number was not provided, therefore review of the manufacturing records could not be completed.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.In addition, they are used in critical care units or ors where patients are closely monitored.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.

Event Description

It was reported that during flushing, the arterial pressure tubing broke and blood leakage was noticed.It is unknown the amount of blood lost.The device was exchanged for a new one and worked successfully.There was no allegation of patient injury.The device is available for evaluation.Patient demographics not obtained to date.

Manufacturer Narrative

The investigation of this vamp adult kit concluded that a potential root cause of detached pressure tubing could be 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

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

• Brand Name: VAMP PRESSURE MONITORING KIT
• 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: 8176363
• MDR Text Key: 131140062
• Report Number: 2015691-2018-05409
• 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
• Report Date: 10/02/2018

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 Model Number: T001670A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/20/2018; 07/23/2020
• Supplement Dates FDA Received: 12/21/2018; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1