MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR VOLUMEVIEW SYSTEM; PROBE, THERMODILUTION

Model Number VLV8R520

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for examination since it was discarded.Nevertheless, an image was provided for evaluation.As per image review, the image showed a non-edwards stopcock.What appeared to be a male luer was noticed inserted into one of the female luer of the stopcock.Based on the image provided, the reported event was not able to be confirmed.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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.Weight based blood volume estimation says that a 65 kg female has approximately 4,225 ml of blood volume.Healthline states that blood volume loss above 40 % will likely make it difficult to treat and correct the blood loss with a transfusion.Hemorrhagic shock initiates when a patient loses approximately 20 % of blood volume, which means that the patient heart is unable to pump enough blood through the body.A loss of greater than 40 % of blood volume is considered exsanguination and can be fatal.In this case the patient would have lost almost 50 % of the blood volume.Information on additional treatment besides a blood transfusion is unknown.The reporter stated that there was ultimately no patient injury.Despite further attempts the customer refused to provide further information.It is unknown if procedural factors were involved in the blood loss.

Event Description

As reported, during use in patient, on this volumeview system, it was found that the thermistor manifold was broken.Approximately 2000 ml of blood was leaked and a blood transfusion was made, however the quantity is unknown.No further details were available.There was no allegation of patient injury.The device was not available for evaluation.

• Brand Name: VOLUMEVIEW SYSTEM
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• MDR Report Key: 12533245
• MDR Text Key: 273355561
• Report Number: 2015691-2021-05373
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/27/2021

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: No Information
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR
• Patient Weight: 65