MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO1316TSA01PL_

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in this event was not returned, therefore it is not possible to determine if there are any nonconformances with the device.The ifu states "a minimum clearing volume of two times the dead space should be achieved." it was confirmed with the customer that their measured clearing volume was 1 cc which is not per ifu instruction.An edwards representative is scheduled to retrain the customer on use of this system.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 a part of the monthly review.

Event Description

As reported, during use of dpt with vamp blood sampling system, clinicians performed blood sampling  in order to test hemoglobin (hgb) of the patient.Per the user, the blood sampling was performed by sampling ¿double amount of preliminary clearing volume¿ in accordance with the ifu.Additional information was confirmed through follow up that sampling was performed from the planecta site on the patient side of the line, and that the amount preliminary clearing volume was 1cc. the user noted a difference in hgb between two blood draws.The first blood draw was 5.5 and the second blood draw was 7.4.This resulted in an alleged inaccurate value of hgb that resulted in the clinician administering albumin.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 10311722
• MDR Text Key: 200773860
• Report Number: 2015691-2020-12638
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VO1316TSA01PL_
• 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
• Patient Weight: 71