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

Lot Number 4321040

Device Problems Nonstandard Device (1420); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)

Patient Problems Headache (1880); Hot Flashes/Flushes (2153); Electrolyte Imbalance (2196)

Event Type  Injury  

Event Description

Inbound call from pt.Pt reports using a recalled cassette lot number 4321040.Pt said she has been experiencing headache and flushing.Pt has unaffected cassettes to use and was advised to switch to one of those.Pt also reported a high pressure alarm with her pumps.She switched to backup pump and was still getting the same alarm.Her mom confirmed it was due to the tubing being kinked in her bra and it has been resolved and pump has been infusing fine with no issues since then.No disruption in therapy reported as a result.Pt's dad also reported pt was in the hospital overnight (exact date not reported) for headache and flushing and was found to have low potassium, which she is to take a supplement for.He said md is aware.No further information provided.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? yes, had some side effects; if yes, was any medical intervention provided? pt was instructed to switch to new unaffected cassette.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.If yes.Was the pt able to successfully continue their infusion? na.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.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: 16094738
• MDR Text Key: 306723075
• Report Number: MW5114149
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: EXTENSION SET; PUMP; VELETRI
• Patient Sex: Female