MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42584-05

Device Problems Detachment of Device or Device Component (2907); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Narrative from staff: patient from cardiac or with standard lines.Arterial line in place.When attempting to draw admission labs was unable to draw back.Internally the plunger had broken and was not attached to the stopper.

• Brand Name: ICU MEDICAL
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15842951
• MDR Text Key: 304098141
• Report Number: 15842951
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42584-05
• Device Catalogue Number: 425840405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male
• Patient Weight: 97 KG