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

Lot Number 4334142

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Spontaneous.Spoke to patient about damaged cassettes.Patient reported the cassettes are damaged and unable to be used with the medication.The patient did not specify how the cassettes were damaged, only stated that they are damaged when she went to use them.Lot number 4334142.Cassettes are going to be replaced.No missed medication.No side effects reported.Pumps are functioning.Patient stated she has one cassette left that is already mixed and in the refrigerator.She said there is possibly two cassettes from the damaged batch that she could use.She is changing her cassette today at 5:30pm.Advised patient that if the medication is abruptly stopped to seek medical help right away at the local hospital.Current dose 67.5nkm, 78ml/24hr pump rate, using 5-1.5mg vials veletri.Titration order: increase dose by 0.5-1ng/kg/min as directed by md.No other information known at this time.No further info.No add'l info, details,k or dates available, pump return tracking info is not available.Photographs were not provided.This is a continuous infusion, set flow rate and volume delivered are unk.Position of the pump when alarmed occurred is unk.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? yes; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? yes, one left, if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE LEGACY
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16294175
• MDR Text Key: 308836768
• Report Number: MW5114647
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4334142
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Patient Sequence Number: 1
• Patient Sex: Female