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

Model Number T001744M

Device Problem Signal Artifact/Noise (1036)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  malfunction  

Manufacturer Narrative

The product involved in this case was not received at our product evaluation laboratory for a full examination since it was discarded.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The lot number for this device was not supplied.Therefore, the related manufacturing records for this device were unable to be reviewed.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, after treatment of a patient admitted in icu with labetalol iv for hypertension over 200 mmhg due to an hypertensive crisis and left basal ganglia hemorrhage, this disposable pressure transducer with vamp system continued providing incorrect high pressure value over 180mmhg due to strong underdamping effect.A non-invasive method was also used and provided values around 120mmhg after treatment.However, customer trusted dpt values; leading to continue the treatment with hypotensive drug and patient going into shock.The patient was okay after the event and was discharged from icu.Dpt underdamping effect is well known by the user and it is defined as overestimated systolic pressure; underestimated diastolic pressure and map not impacted but is concerned because this effect is occurring more frequently and stronger since a dpt with vamp model instead of dpt without vamp is being used.The device was not available for evaluation since it was discarded.

• Brand Name: VAMP PLUS 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15560938
• MDR Text Key: 301498776
• Report Number: 2015691-2022-08427
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K181684
• 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: Other
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001744M
• Device Catalogue Number: T001744M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG