MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number T470411B

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

As reported, during use in patient with this pressure monitoring set with vamp jr (medwatch # 12513), a lot of air was aspirated into the vamp reservoir when blood was drawn.The vamp jr set was disconnected and removed.The device was replaced with a new set to solve the issue.However, after 6 days, the same issue happened again (medwatch # 12514) with the same patient.The issue was solved using a third set.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The following two suspected lot numbers 63756605 and 63423588 were provided regarding the reported device.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Manufacturer Narrative

One pressure monitoring set with vamp jr was received by our product evaluation laboratory for a full examination.The report of air aspirated was not able to be confirmed during evaluation.As received all connections were tight and secured.It was able to prime throughout the kit without indication of occlusion or flow restriction.Simulated use test was performed to the vamp jr., no air aspiration or leakage was observed during simulated use test per ifu recommendations.It was recommended by ifu to move the plunger of vamp jr.At rate of "approximately 1 ml every 10 to 15 seconds" during aspiration "(approximately 30 to 45 seconds to fill the reservoir to capacity)".No leakage was observed from the entire kit during leak test.The manufacturing records were reviewed for the two suspected lot numbers involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation, since no defect was found in the unit during product evaluation, it could be concluded that the failure reported can be attributed to user error.Based on a review by product safety, the potential reasons for having air in the system could be related to rapid pulling when drawing into the reservoir, loose connection, air pockets spontaneously form while the syringe is attached to the pump on running of an empty line (the syringe runs out of fluid that is keeping the line open).This product has an instructions for use, which contains clear instructions on how to properly use vamp system, pressure monitoring set.Additionally, as part of the manufacturing process and as control points for this malfunction, leak tests and visual inspections are carried out on the manufactured units.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.

• Brand Name: VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13514051
• MDR Text Key: 285747402
• Report Number: 2015691-2022-03899
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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: T470411B
• Device Lot Number: 63756605, 63423588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 12 KG