MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR LEGACY; SET, I.V. FLUID TRANSFER

Lot Number 4284652

Device Problem Nonstandard Device (1420)

Patient Problems Arrhythmia (1721); Diaphoresis (2452)

Event Type  Injury  

Event Description

Patient reported having symptoms during the night of palpitations, night sweats on two occasions over past month.Not sure if related to recalled cassettes for his iv remodulin [self mix] patient feeling good now, no issues with infusion.Patient only has cassette that are on recall, lot number 4284652, had to ship replacement cassettes.No further.Information.Iv remodulin pt.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not produced.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR LEGACY
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16025939
• MDR Text Key: 305995863
• Report Number: MW5113887
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4284652
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male