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

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Spontaneous call from pt, pump was alarming for "no disposable".Pt tried to realign the cassette and the pump, then switched that same cassette to the back up pump - got same alarm; pt was advised to use another cassette and restart infusion, pump is not at fault -alarm is due to defective cassette - unknown lot number.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 cassette available for investigation? no did we replace cassette? no; did the patient have more cassettes they were able to switch to? yes; was the patient able to successfully continue their infusion? yes; 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: 12662585
• MDR Text Key: 277633797
• Report Number: MW5104749
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 62 YR