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

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient advised cassettes that she was using had been discolored but she used them anyways.This reporting was based off documentation that pharmacy representative had entered in to their system on (b)(6) 2022.Per note, patient refused to speak to a pharmacist there is no lot number available for the cassette.It is unknown if it resolved itself as there are no other information available.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? unk; is the actual cassette available for investigation? unk; did we [mfr] replace the cassette? unk; did the pt have add'l cassettes they were abel to switch to? unk; is the infusion life-sustaining? yes; what is the outcome of the event? ongoing.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: 13976568
• MDR Text Key: 288495878
• Report Number: MW5108680
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female