MAUDE Adverse Event Report: ICU MEDICAL, INC. PLUM 360; PUMP, INFUSION

Model Number 30010

Device Problems Device Alarm System (1012); Failure to Infuse (2340)

Patient Problems Low Blood Pressure/ Hypotension (1914); Asystole (4442)

Event Date 09/23/2022

Event Type  Death  

Event Description

Cicu (cardiac intensive care unit)- patient (pt) was hypotensive persistently, despite decreasing shift therapy uf; rn started vasopressin at 2131h because bp (blood pressure) was hypotensive- pt is on levo at 20.2141h bp improved after vasopressin and decreasing uf to 200 ml/hr.2147h- bp persistently low for 2 readings, provider informed, 2155h- provider at bedside, levophed dose increased to 30 mcg, shift therapy still ongoing- levophed was not infusing because of "alarm vol complete".Provider witnessed.Per rn, alarm not audible from outside the room.Alarm on approximately 75% volume per adjustment knob-, rn checked volume of the levo on handoff; however programmed vtbi (volume to be infused) cannot be confirmed-.2201h - levophed bag re hung; bp no improvement, shift therapy machine stopped.2207- bp 48/13, no change, crrt (continuous renal replacement therapy)/pirrt (prolonged intermittent renal replacement therapy) stopped while in the room.2225h- asystole on monitor, no pulse noted.2231h- time of death.

• Brand Name: PLUM 360
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 600 n field dr; lake forest IL 60045
• MDR Report Key: 15804245
• MDR Text Key: 303723314
• Report Number: 15804245
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30010
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2022
• Date Report to Manufacturer: 11/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death