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

Lot Number 4329614

Device Problems Device Alarm System (1012); Nonstandard Device (1420); Output Problem (3005)

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

Event Type  Injury  

Event Description

Patient reported having the following recalled cassette lots and quantities: lot 432961410 cassettes, lot 4315909 one cassette, lot 4298336 three cassettes.Expiration dates unknown.Patient reported no current symptoms and unsure of current lot of cassette in use.Patient reported he had to change cassette with unknown lot yesterday due to non disposable alarm for about 5-6 hours and then changed cassette on same pump and alarm stopped.Patient not reporting any symptoms at this time.Patient does report yesterday experienced a little shortness of breath.Last mix was 5 or 6 pm, yesterday.Not currently having any symptoms.Pharmacist reviewed to go to hospital if experiencing any shortness of breath or symptoms before new cassettes arrive.Patient understood.Patient due to change cassette tomorrow evening.No additional information at this time.Pump return tracking info is not applicable.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when alarm occurred is unk.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? no; is the actual product available for investigation? unk; 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; 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: 16069150
• MDR Text Key: 306424868
• Report Number: MW5114067
• 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: 12/19/2022
• 14 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4329614
• 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: Male