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

Lot Number 4329615

Device Problems Device Alarm System (1012); Nonstandard Device (1420); Device Slipped (1584)

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

Event Type  Injury  

Event Description

Patient reported she has the following recalled cassettes in her possession: two cassettes lot: 4329615, two cassettes lot: 4321040, one cassette lot: 4298336 (expiration dates unknown].Asked her to quarantine and wait for return box and ship back to pharmacy.No symptoms or side effects right now with cassette that is attached to pump at this time with unknown lot number, advised to continue infusion.Patient reported that around a week ago (b)(6) 2022 she had no disposable alarm while infusion was running and she was able to fix it (patient changed cassette, unknown lot numbers), resumed infusion on the same pump and she continued infusion without interruption and no side effects.Patient's line was changed around a week ago (b)(6) 2022, patient accidently pulled out her line during cleaning and went to emergency department right away.She stayed there for 15 hours until she had new line.Placed and was discharged, no issues since then.Unknown if patient was admitted to hospital for line placement.Date patient left emergency department was unspecified.No other information provided.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.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: 16068143
• MDR Text Key: 306430502
• Report Number: MW5114060
• Device Sequence Number: 1
• 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: 12/22/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

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: 4329615
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female