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

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient reported she was sick in bed and had decreased the veletri dose due to unspecified side effects on (b)(6) 2021.No further information is known regarding side effects.Unknown if (b)(6) is aware.Event start and end dates are unknown.Patient self down titrated veletri: dose ung/kg/min, 74 ml/24hr pump rate, using 1 - 1.5mg vial.Titration order: increase dose by 1ng/kg/min every 14 days until goal of 20ng/kg/min.Patient also reported that pump serial number (b)(4) has been alarming continuously.Pt tried to fix by checking the line and changing the cassette but nothing resolved it.Pt switched to pump serial number (b)(4) and that pump alarmed for cassette issue.Pt made a new cassette and it stopped alarming.For pump serial number (b)(4), pt states it was a cassette issue and not a pump issue.Cassette lot number unknown.No further information is known.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; did we 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.Pump serial number: (b)(4) was replaced and new cassettes also dispensed, resolved? yes; ongoing? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12967574
• MDR Text Key: 282049478
• Report Number: MW5105939
• 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: 12/06/2021
• 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: 12/08/2021
• Patient Sequence Number: 1
• Patient Sex: Female