MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT [VAMP]; KIT, SAMPLING, ARTERIAL BLOOD

Model Number T001691A

Device Problems Disconnection (1171); 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 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt vamp plus kit was received for evaluation.The reported event of tubing issue was confirmed.As received, the adhesive white tape was found between the pressure tubing and the female connector attached to the zero-stopcock.Once the tape was removed, it was visible that the pressure tubing had been completely detached from bond joint with female connector.Indications of bonding material were evident on surface of the pressure tubing and the female connector.Tubing outer diameter, near the point of detachment, was within specification.Dry blood was noted inside the stopcock , sampling site and distal pressure line (proximal to patient).No other visible damage was observed from the returned kit.Further investigation has been assigned for any manufacturing related non-conformances.  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.In this case, there were no patient impact.  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 a part of the monthly review.

Event Description

As reported, at the time of a blood test in patient of this pressure monitoring set with vamp, a tubing disconnection occurred on the tubing female connector between the dpt and vamp.Blood leakage of approximately 20ml occurred.There was not consequence or injury to the patient.The device was changed to solve the issue.The device was available for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further investigation of the detached tubing on the dpt vamp system, the most probably root cause was determined to be the improper execution of the solvent bonding process.A personnel acknowledgment was given to all potential manufacturing resources.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 a part of the monthly review.

• Brand Name: PRESSURE MONITORING KIT [VAMP]
• Type of Device: KIT, SAMPLING, ARTERIAL BLOOD
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 10311404
• MDR Text Key: 201062105
• Report Number: 2015691-2020-12634
• Device Sequence Number: 1
• Product Code: CBT
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001691A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 76