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

Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient to report her pumps were alarming, this happened while in use and patient switched to backup pump and got same alarm.Patient made a new cassette and hooked up to pump and was able to start infusion.Not a pump issue but a cassette issue.Patient did not have a lot number for the cassette.Patient did not experience any side effects.No other information known.Did we [mfr] replace device? no.Did the patient have a backup device they were about to switch to? yes.If yes was the patient able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? unknown.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 11250725
• MDR Text Key: 229592064
• Report Number: MW5099076
• 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: 01/24/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Patient Sequence Number: 1
• Patient Age: 29 YR