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

Lot Number 4321040

Device Problem Nonstandard Device (1420)

Patient Problems Diarrhea (1811); Dyspnea (1816); Headache (1880); Nausea (1970); Vomiting (2144); Peripheral Edema (4578)

Event Type  Injury  

Event Description

Patient reported she has 8 cassettes affected by recall, lot: 4321040, expiration date unknown.Patient does not have any cassettes on hand that are not affected by recall.Explained recall to patient and patient said that she has been feeling awful for the last month.Nausea, diarrhea, vomiting, headache, and swelling in her legs.Patient said she also has been having difficulty breathing.Advised patient that since she did not have any cassettes not affected by recall and she is having symptoms that we recommend going to the er.Patient at first sounded like she was going to go but then said she could not leave work.Patient is refusing er right now after multiple attempts to encourage her to go.Communicated issue to md.Exact start date of events is unknown.No other information known.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes.If yes, was any medical intervention provided? pt.Was encourage to go to er.Is the actual product available for investigation? no.Did we replace the product? yes.Did the patient have a backup product they were able to switch to? no.Was the patient able to successfully continue their therapy? with impacted cassette.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICATION ASD, INC.
• MDR Report Key: 16051374
• MDR Text Key: 306318161
• Report Number: MW5114009
• 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
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4321040
• 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