MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL PLUM PUMP; PUMP, INFUSION

Model Number 30010-04-13

Device Problems No Audible Alarm (1019); Air/Gas in Device (4062)

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

Event Date 04/14/2023

Event Type  Other  

Event Description

Air alarm did not sound when air passed iv cassette.

• Brand Name: ICU MEDICAL PLUM PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 16771161
• MDR Text Key: 313666665
• Report Number: MW5116837
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30010-04-13
• Device Catalogue Number: 11198692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR