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)

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

Event Type  malfunction  

Event Description

Spontaneous communication from patient stating that she has had issues with her pump serial number: (b)(4).Due date unknown since she received it, patient is getting alarms with no display of any alarm code.Patient was informed of cassette recall and advised that it may be a cassette issue not necessarily a pump issue but that we would replace both.Patient has 7 cassettes on hand all affected by recall.Lot: 4329614, expiration date unknown.Patient switched to backup pump and cassette without issue.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 cassette available for investigation? yes.Did we [mfr] replace the cassette? yes.Did the pt have add'l cassettes they were able to switch to? yes, recalled.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of pump when alarm occurred is unk.No add'l info is available at this time.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: 16121632
• MDR Text Key: 307001216
• Report Number: MW5114215
• 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: 12/15/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• 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
• Patient Sex: Female