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

Lot Number 00000044927

Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)

Patient Problems Diarrhea (1811); Headache (1880); Pain (1994)

Event Type  Injury  

Event Description

Spontaneous call from pt.Spoke to patient she is still experiencing some headaches, jaw pain and diarrhea.Says her md is aware of this and the side effects are tolerable.Advised patient if the side effects become worse or new side effects occur to let us and the mdo know.Patient understood.Patient did have an issue with a cassette approximately a week ago.The reported product fault did occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The event is resolved.This incident has happened within the past 6 months.This patient has reported a pump malfunction within the past 6 months.Patient had her pump replaced recently.Her husband drew up another mix and replaced the cassette and the issue resolved.Patient is doing well.Patient did not save cassette.Patient unsure of exact type of alert, just that it was a no disposable alert no other info/dates provided.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? no; did we replace the cassette? she is ordering refill today; 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: 15446236
• MDR Text Key: 300252379
• Report Number: MW5112107
• 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: 09/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 00000044927
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1