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

Model Number 48VMP106

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 04/02/2019

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

As reported, during use in a (b)(6) year old male patient, in this vamp adult system, serum and blood leakage in the ¿rubber path¿, (leakage at the plunger seal), was observed.The device was exchanged for a new one and worked successfully.There was no allegation of patient injury.The vamp system was available for evaluation.

Manufacturer Narrative

One vamp adult system was returned for examination.The reported event of "blood leakage in the rubber path" was confirmed.As received dry blood was evident on the plunger side of the blue seal and on the inside of the contamination shield.Blood residues were evident between the seal and the reservoir.It was apparent that blood had leaked past the blue seal to the plunger side and out of the reservoir cap into contamination shield.A simulated use test was performed to the vamp system in attempt to recreate how blood passed the seal into plunger side.But no leakage was detected past the seal during simulated use test if the ifu recommendations were followed.The ifu recommends to smoothly and evenly move the plunger at rate of 5ml per 3-5 seconds during aspiration and injection of blood from the reservoir.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.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.In this case, there were no patient complications noted.A complaint of blood past the plunger seal can be due to a manufacturing non-conformance or user technique.In this instance evaluation lab testing demonstrated that the device worked correctly when properly used.It is possible that user or procedural factors contributed to the event.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.

Manufacturer Narrative

Please see manufacturing and expiration date associated with the lot number.

Manufacturer Narrative

The investigation of this vamp adult system concluded that a potential root cause of blood leaking past the blue seal could be related to an incorrect solvent bonding execution during the assembly process and/or the malpositioning of the seal in the plunger.Personnel notification was performed.

Manufacturer Narrative

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

• Brand Name: VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• 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: 8542024
• MDR Text Key: 143436863
• Report Number: 2015691-2019-01425
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 48VMP106
• Device Lot Number: 61533061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1