MAUDE Adverse Event Report: ICU MEDICAL SAFESET TRANSPAC IV MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42648-06

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

Patient had an arterial line that was being transduced through the cardiac monitor.The transducer was not working so the rn attempted to problem-solve the situation.She tried multiple tactics and discovered that the tubing was the issue.This is what the patient safety report stated: changed patient's arterial line tubing, arterial line wave form was appropriate and blood was able to be drawn back.Arterial line had difficulty zeroing and once zeroed, the blood pressure was grossly inaccurate.Incidents with this device have now happened at three different departments in the hospital.Manufacturer response for transpac iv monitoring kit, (per site reporter): i contacted a complaint processing associate.She said she is contacting my representative to get the process started in returning the device for investigation.

• Brand Name: SAFESET TRANSPAC IV MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6954386
• MDR Text Key: 89499814
• Report Number: 6954386
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 42648-06
• Device Catalogue Number: 42648-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE CARDIAC MONITOR AND PRESSURE CABLE WERE RULED
• Patient Outcome(s): Other