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

Lot Number 4298336

Device Problem Nonstandard Device (1420)

Patient Problems Fatigue (1849); Hypoxia (1918); Respiratory Insufficiency (4462)

Event Type  Injury  

Event Description

Patient reported possession of affected cassette lot numbers [4298336, 4235242, 4321040, 4168794, 4235231, 4257808, expiration dates unknown).No viable cassettes to use for her next mix.Patient has been experiencing symptoms of shortness of breath and weakness for about 1-2 weeks.Patient has cardiomems implant [reads pulmonary pressure] and recorded results were not improving and in fact worsened md is aware.Patient is not having any issues with current cassette.Informed patient to call pharmacy if any issues.Pharmacy to send replacement cassettes.Encouraged patient to go to the hospital if any issues with current mix.Patient is on oxygen and had to use more oxygen over the last 2 weeks or more.Patient does believe cassette recall contributed to adverse events/side effects being reported.Unsure of the lot numbers of the cassettes.The pt was infusing at the time of the symptoms.Dose or amount: treprostinil 32.66 ng/kg/min.Pump return tracking info is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when alarm occurred is not applicable.No add'l info is available at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? yes; if yes, was any medical intervention provided? no; is the actual product available for investigation? yes.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: 16148397
• MDR Text Key: 307274663
• Report Number: MW5114283
• 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
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4298336
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female