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

Device Problems Failure to Infuse (2340); Defective Device (2588)

Patient Problem Anemia (1706)

Event Type  Injury  

Event Description

Pt's spouse reports that pt is being treated for iron deficiency anemia; no details provided.Pt's spouse also reports that both of pt's pumps have alarmed in the past week indicating that the cassette needed to be changed early.Spouse reports pt had to waste medication in 2 cassettes but was able to continue their infusion after changing to a new cassette.Spouse reports they only kept the most recent defective cassette and they do not have the label/packaging that the cassettes came in that provided the cassette lot number(s).Pt's spouse declined pharmacy offer to have new pumps dispensed at this time.Spouse stated that they believe the problem is with malfunctioning cassettes and not the pumps.Spouse denies that the pt experienced any changes to their breathing or other side effects due to malfunctioning cassettes.Unknown if md is aware of any/all event.No add'l info, details, or dates available.This is a continuous infusion, set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Pump return tracking info is not available.Photographs were not provided."iv remodulin pt." pt's actively taking remodulin, opsumit and sildenafil.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 - one of them; 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? 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 MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17070913
• MDR Text Key: 316682923
• Report Number: MW5118176
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2023
• Patient Sequence Number: 1
• Patient Sex: Female