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

Lot Number 4321040

Device Problem Failure to Infuse (2340)

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

Event Type  Injury  

Event Description

Spoke to patient to notify them of cassette device correction, pt reports lot 4321040, 4329614.Currently patient stating no symptoms, she is due to mix at lpm.She stated she had a cassette malfunction a few days again.Pump wasn't infusing, pt remixed and used new cassette and resumed and it was fine.However, she said she had more side effects with that cassette.She did not specify which side effects.She said they subsided though.Iv remodulin pt.No add'l info, details, 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 alarm occurred is unk.Did the reported product fault occur while in use with the pt? unk; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? unk.Did we [mfr] replace the cassette? yes; did the pt have add'l cassettes they were able to switch to? unk; is the infusion life sustaining? yes; what is the outcome of the event? shipped 1 wk of new cassettes; 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: 16026171
• MDR Text Key: 306068959
• Report Number: MW5113898
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female