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

Lot Number 4329617

Device Problem Nonstandard Device (1420)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Patient's wife confirmed recalled cassettes in possession, provided lot: 4315909, 4329617 all affected, expiration dates unknown.Wife stated patient was hospitalized a few weeks ago.Reason fer hospitalization, admission/discharge/length of stay unknown and whether affected cassettes contributed to the hospitalization is unknown.It is unknown if they were infusing with recalled cassette at that time.Patient's wife denies any symptoms currently.No other information provided.Dose or amount: treprostinil 69.5 ng/kg/min.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Setflow 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 pt? yes; did the product issue cause or contribute to pt or clinical injury? uncertain; if yes, was any medical intervention provided? hospitalization did occur; is the actual product available for investigation? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16086062
• MDR Text Key: 306609693
• Report Number: MW5114107
• Device Sequence Number: 2
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329617
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTENSION SET; PUMP; TREPROSTINIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Male