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

Lot Number 3891159

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/13/2020

Event Type  malfunction  

Event Description

Spontaneous call pt states that pump alarmed with a ¿non disposable¿ message.Pt changed cassettes and was able to infuse properly.Pt believes cassette maybe faulty.Pt provided lot number: 3891159, expiration: 10/24/2024.No other information known.Was the patient abel to successfully continue their infusion? yes is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Did the reported pump fault occur while in use with patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available to be returned for investigation? yes.Did we (mfr) replace device? pt had extra cassettes.Reported to (b)(6) pt/caregiver.

• Brand Name: CASSITTE MEDI RESERVOIR
• Type of Device: SET, I.V, TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10167676
• MDR Text Key: 195941705
• Report Number: MW5095062
• 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: 06/13/2020

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: No Information
• Device Lot Number: 3891159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2020
• Patient Sequence Number: 1
• Patient Age: 49 YR