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

Model Number 42801-35

Device Problems Difficult to Flush (1251); Obstruction of Flow (2423)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

Art line tubing noted to have clotted off and not functioning properly.Once removed, sizable clot noted in tubing.Rn stated that this product flushes slower than normal tubing.Item is a sub-product due to item backorder.

• Brand Name: ICU MEDICAL
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 15833641
• MDR Text Key: 304009378
• Report Number: 15833641
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 42801-35
• Device Catalogue Number: 42801-35
• Device Lot Number: 6033681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Male