MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360 PUMP; PUMP, INFUSION

Catalog Number UNKNOWN

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

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The manufacturer has requested more information regarding the event and the device involved.If new information becomes available, a supplemental emdr will be submitted.

Event Description

Icu medical received a medsun mandatory medwatch report (mdr report # mw5115347) on (b)(6) 2023.The event involved a plum 360 pump where it was reported that the intravenous (iv) pump air in line alarm did not sound.Air was noted in line prior to connecting to patient.The alarm malfunctioned.It was also reported that there was a required intervention (not specified).There was patient involvement but no report of patient harm.No additional information was provided at this time.

• Brand Name: UNSPECIFIED PLUM 360 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16682553
• MDR Text Key: 312891017
• Report Number: 9615050-2023-00101
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1