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

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient who reports about pump 336490 that had alarmed no disposable and pump stopped.Patient said the pump was saying that there was 11.4ml left in the pump but the cassette looked empty.Patient denies any wetness anywhere and did not feel any different (in case she got too large of a dose) patient had already switched to back-up pump and was infusing.No lot information available for cassette.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? cassette: yes, pump: unknown did we [mfr] replace device? yes for pump, cassette no, did the patient have a backup device they were able to switch to? yes if yes, was the patient able to successfully continue their infusion? yes.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12689309
• MDR Text Key: 278536529
• Report Number: MW5104918
• 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: 03/11/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR