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

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Itching Sensation (1943)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Spontaneous call from the patient stating that the backup pump had failed.Patient was sent to the hospital.While at the hospital, the failed pump was restarted by (b)(6).There was minimal interruption to therapy.Pump did not need to be replaced.No further intervention was needed.No further information is known.Serial number of pump: (b)(4).The fault did occur while in use.The patient did not have any ill effects or clinical injury.No intervention was needed or provided to/for the patient.The device will be available to investigate once (b)(6) gets it back from the patient.Did we [mfr] replace device? yes; did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes.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: 11307668
• MDR Text Key: 231405229
• Report Number: MW5099330
• Device Sequence Number: 3
• 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: 02/08/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 29 YR