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

Lot Number 4329614

Device Problems Nonstandard Device (1420); Pressure Problem (3012)

Patient Problem Fatigue (1849)

Event Type  Injury  

Event Description

Pt reports they have 11 cassettes with recall affected lot numbers: 4329614, 4321040, 4298336.Pt has no cassettes with unaffected lot numbers.Pt reports they had issues with 3 previous cassettes [lot number unknown] - would say high pressure in pt's pump (serial number unknown) and pt had to replace those cassettes.Next cassette change is due tomorrow (b)(6) 2022.Pt also reports they haven't been feeling as well, more fatigued; onset/ resolution dates/status unknown.Pt has not notified md yet.No further info, details or dates available.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? yes; did the product issue cause or contribute to pt or clinical injury? unk; 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? 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: 16043544
• MDR Text Key: 306315323
• Report Number: MW5113993
• 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: 12/19/2022
• 14 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4329614
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female