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

Lot Number 4298336

Device Problems Nonstandard Device (1420); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient reported she has the following recalled cassettes in her possession; lot number: 4298336 quantity: 1 box, lot number: 4329614 quantity: 1 box, and has 2 cassettes premade in the fridge with lot number:4315908.Patient is not having symtoms, however pump was beeping "no disposable pump won't run" a few days ago with lot number 4315908 expiration date unknown.Patient changed cassette and continued infusion without issues.Patient wants to use the two pre-made cassettes in the fridge first (even after being advised of the recall).Patient was advised to call back once ready for cassette shipment.Dose or amount: treprostinil 78.5 ng/kg/min.Pump return tracking information is not applicable.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is unknown.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? no; is the actual product available for investigation? no; did we [mfr] replace the product? no; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their therapy? yes; is the therapy life sustaining? yes; reported to cvs/caremark 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: 16042709
• MDR Text Key: 306272791
• Report Number: MW5113947
• 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
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4298336
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL ; TUBING
• Patient Sex: Female