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

Lot Number 4321040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dizziness (2194)

Event Type  Injury  

Event Description

Solicited call.Iv remodulin patient using cadd legacy pump.Spoke with patient regarding cassette recall.Pt has affected lots# 4329615-13, 4321040-5.Pt does not have any good lots.Pt reports being lightheaded.Patient currently infusing with affected lot.Patient stated that he just got out of the hospital (2 week stay using iv remodulin drip from the hospital supply.) patient resumed using his remodulin and cassettes on (b)(6) 2022.Patient is unsure if the lightheadedness is related to the cassette recall or recent hospitalization.Patient due to mix today [around 4pm - 11.3 ml remaining in the pump].Replacement cassettes will be shipped today to arrive 12/20/22.No other information is known.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16043532
• MDR Text Key: 306316574
• Report Number: MW5113991
• 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: 12/19/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Male