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

Device Problem Defective Device (2588)

Patient Problem Skin Discoloration (2074)

Event Type  Injury  

Event Description

Spontaneous.Pt's mother reports pt experienced a pump alarm (message unknown) on sunday night (b)(6) 2022, so they took pt's cassette off and reattached it with no further issues.On tuesday (b)(6) 2022 at 2:15am, pump alarmed (message unknown) and they switched pt to back up pump and that one also alarmed (message unknown), so they switched to third pump, which worked.They used 1 extra premix cassette in that time (on tuesday morning (b)(6) 2022).Patient experienced an adverse event; per mother, patient looked pale.It is suspected, but not confirmed, that the remodulin infusion had been stopped for an unknown length of time.Pt's mother does not want any new pumps sent at this time as she thinks the cassette was faulty, not the pumps.Lot number of malfunctioning cassette is not known.Instructed mother to keep defective cassette in case manufacturer wants it returned.No additional info, details or dates are available at this time.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.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? no; is the actual product available for investigation? yes; did we [mfr] the product? yes; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their therapy? yes; reported to cvs/caremark by pt/caregiver.

• Brand Name: CASSETTE MEDI RESREVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15085619
• MDR Text Key: 296469793
• Report Number: MW5111050
• 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: 06/28/2022
• 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: 07/21/2022
• Patient Sequence Number: 1
• Treatment: LEGACY PUMPS
• Patient Sex: Female