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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Spontaneous call from patient's wife.Pump giving "no disposable" alarm.Pump was operating without any problems the previous day.Patient switched to backup.Back up pump also alarmed with same warning.Advised that problem is likely with the cassette and not the pump.Advised wife to mix a new cassette.Patient did not experience any adverse events.Fault did occur while pump was in use.No clinical injury.Cassette is available for investigation.Wife does not have the lot/expiration number of the faulty cassette.The infusion is life sustaining.Event is resolved.Did we replace device? 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.No other details available.Reported to (b)(6).

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10250660
• MDR Text Key: 198393816
• Report Number: MW5095451
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 58 YR