MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR; KIT, SAMPLING, ARTERIAL BLOOD

Model Number 48VMP160

Device Problems 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 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

One vamp adult kit was returned for examination.The reported event of ¿saline leakage from stopcock ¿was confirmed.As received the tubing had detached from the bond joint with a vamp adult reservoir stopcock.The tubing was bent near the point of detachment.Indications of bonding solvent were evident on 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.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, no patient compromise was reported as the issue was noted before use.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

It was reported that before use of this dpt (disposable pressure transducer), saline leaked from the stopcock.Replacing the device resolved the issue.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The investigation of this vamp adult kit concluded that a potential root cause 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 VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR
• 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: 8668563
• MDR Text Key: 147321286
• Report Number: 2015691-2019-01992
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• PMA/PMN Number: CLASS I EXEM
• 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: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 48VMP160
• Device Lot Number: 61386314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 73