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

Catalog Number UNKNOWN

Device Problem Unexpected Shutdown (4019)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that in the course of 15 minutes, the plum a+ shut off while infusing critical medications.The pump was plugged in at the time the patient's blood pressure dropped by 40 points and the patient awoke agitated with an impelled device in place that required lying still.Reference report (b)(4).There was patient involvement and no harm to the patient was reported.No additional information is available at this time.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

• Brand Name: PLUM A+
• 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: 16808216
• MDR Text Key: 314120179
• Report Number: 9615050-2023-00116
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN CRITICAL MEDICATION.