MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD DTX PLUS TRANSDUCER/ BLOOD SAMPLING SYSTEM; BLOOD SUPPLY SYSTEM

Catalog Number 096002-000-599

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device will be returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a recent spinal surgery procedure, the anesthetist claimed that they were trying to maintain the patient's blood pressures to ensure spinal cord perfusion when they noticed a fairly significant increase in arterial pressures, over the course of a few minutes, which was initially corroborated with non-invasive blood pressures measurements.The systolic pressure allegedly rose from 140mmhg to over 200mmhg.They attempted to treat the patient's hypertension unsuccessfully with magnesium sulphate.Eventually, the arterial line transducer, was re-zeroed again, only to find that the actual systolic blood pressure was closer to 65mmhg.This reading required urgent and aggressive intervention with successful vasopressor administration.No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The issue noted by the user could not be reproduced.The complaint could not be confirmed an the root cause could not be determined.A review of the device history record was performed, and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: DTX PLUS TRANSDUCER/ BLOOD SAMPLING SYSTEM
• Type of Device: BLOOD SUPPLY SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD; 198 yishun ave 7; 76892 6; SN 768926
• MDR Report Key: 9501122
• MDR Text Key: 176826877
• Report Number: 8020616-2019-00147
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 096002-000-599
• Device Lot Number: C1634626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention