MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VAMP JR. VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM; KIT, SAMPLING, ARTERIAL BLOOD

Model Number VMP406

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.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.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Since these devices are indicated for pediatric patients, whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults.Consequently, there is potential for patient injury.In this case, there were no patient complications 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

As reported, during use with pediatric patient of this pressure monitoring set with vamp jr, blood leakage was noted when connecting blood management protection device.The device was immediately replaced.1 to 3 drops of blood leaked, less than 1 ml.Leakage occurred between the piston with blue seal and the shut-off valve.Another vamp406 was used and no additional interventions were needed.Patient demographics are unknown.There was no allegation of patient injury.The product was not available for evaluation since it may have been exposed to category a infectious disease.

Manufacturer Narrative

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

• Brand Name: VAMP JR. VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Type of Device: KIT, SAMPLING, ARTERIAL BLOOD
• Manufacturer (Section D): EDWARDS LIFESCIENCES; parque industrial de itabo; carr. sanchez km 18.5; irvine ; DR
• MDR Report Key: 9916351
• MDR Text Key: 188670682
• Report Number: 2015691-2020-11279
• 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
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Model Number: VMP406
• Device Lot Number: 61912324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1