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

Lot Number 4329614

Device Problems Nonstandard Device (1420); Difficult or Delayed Activation (2577); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Patient confirmed they are in possession of recalled cassettes.When patient tried to hook the pump to cassette, the pump went off giving the message pump will not work.Patient stated she got pump to work after changing the cassette a few times.Unknown lot number of the defective cassette that caused error or lot number of the cassette that patient switched to once she was able to resume infusion.Lot numbers affected: 4329617 and 4329614,.No more information or dates provided.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 known.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? yes; 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: 16043511
• MDR Text Key: 306271941
• Report Number: MW5113988
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): N
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329614
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female