MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient reporting two-tone alarm with "no disposable pump won't run" displayed on the screen of her pump 427737.She stated that the same thing had happened last night with her other pump.When it alarmed last night, she tried some trouble shooting and resolved the issue by using a new cassette in the other pump.However, the same cassette is now beeping in the backup pump.She tried moving the cassette back into the other pump, tried changing the batteries and tried changing the tubing.None of that stopped the alarm.Advised her to use a new cassette and she was able to resume the infusion.Confirmed that pump was working when call ended.Patient believes that the cassettes are faulty, no lot information given.No other information provided.Did the pt have a backup device they were able to switch? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.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? no; is the actual device available for investigation? yes; did we replace device? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12615332
• MDR Text Key: 276349904
• Report Number: MW5104510
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR