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

Model Number 300100405

Device Problems Premature Discharge of Battery (1057); Pumping Problem (3016)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ventilator Dependent (2395); Obstruction/Occlusion (2422); Respiratory Failure (2484)

Event Date 10/17/2022

Event Type  Death  

Event Description

Patient suffered a st-elevation myocardial infarction (stemi) and was brought to cath lab after being found down at home.Cardiac cath showed a 100% thrombotic occlusion in the left circumflex artery which was ballooned and stented with a drug-eluting stent (des).The artery was opened down to 0% blockage.Patient suffered acute respiratory failure requiring intubation and ventilator support.Vasopressors were required to maintain his blood pressure.About 6-7 hours post intervention, he had an unexpected drop in his blood pressure.About the same time, the rn went to exchange the levophed iv bag out for a new one as it was nearing empty.The iv pump infusing the levophed started to alarm "cassette failure".Another iv pump was obtained, and they attempted to switch the medication to this pump and it too malfunctioned, stating battery will not charge.The patient proceeded to go into cardiac arrest.Pulseless electrical activity (pea) rhythm was noted, cpr and acls measures were implemented without return of function.After 20 minutes of acls, the patient died.

• Brand Name: PLUM 360
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15702833
• MDR Text Key: 302731146
• Report Number: 15702833
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 300100405
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White