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

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2020

Event Type  malfunction  

Event Description

Spontaneous call from patient.Patient reports her pump with serial number (b)(4) was alarming with two short beeps.Patient did stop the infusion for 5 to 10 minutes while trying to figure this out.Pt's other pump had problems yesterday and she was waiting for a replacement that had been couriered.Patient turned it back on and got a no disposable alarm.She disconnected the cassette and then wiped it clean.After that the pump started working again and patient started to infuse.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? yes; did we (mfr) replace device? no.Did the pt have a backup device they were able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved? ongoing? 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: 10442867
• MDR Text Key: 204248466
• Report Number: MW5096207
• Device Sequence Number: 3
• 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: 08/16/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR