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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Last weekend, patient had a no disposable pump won't run malfunction and her mom had to call 911 to have her taken to the er because she was having changes in breathing.Once at the hospital she was administered intravenous remodulin and was discharged the same clay.Patient was never admitted but was treated in the er.She did have some headache and light headedness when she restarted, but she's doing well now.Patient's mom believes it was a cassette issue since the same issue happened with both pump, but she would feel better with a replacement for the pump due 12/21/2022 [serial (b)(4)] which is the one patient is not currently using to infuse.She would feel better having a new one because of this event.Cassette lot number unknown.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.No further information known.All known info is contained on this form.If any add'l info is received, it will be provided on a separate report.Product event is for one pump and one cassette.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; if yes, was any medical intervention provided? yes; pt went to the er; is the actual cassette available for investigation? unk; pump is; did we replace the cassette? yes and pump; did the pt have add'l cassettes they were able to switch to? no; if no, what was the pt instructed to do in able to continue their infusion? go to ther; 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: 14800899
• MDR Text Key: 294926000
• Report Number: MW5110486
• Device Sequence Number: 2
• 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: 06/21/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2022
• Patient Sequence Number: 1
• Patient Sex: Female