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

Device Problem Defective Device (2588)

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

Event Date 03/23/2021

Event Type  malfunction  

Event Description

Spoke with patient's daughter who stated both pumps are showing no disposable found.Patient noticed that first pump was beeping at 4am and she changed the pump to backup and after a few hours later backup pump was also beeping.Patient was asleep during the initial error.Author advised to change the cassette and retry both pumps.After new cassette was started both pumps were functioning properly.Author concluded that patient likely rolled on to pump and cassette causing the malfunction.Patient did not report any adverse events or worsening of breathing or symptoms.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 product available for investigation? no, did we replace product? no, is the infusion life-sustaining? yes.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, is the infusion life-sustaining? yes, what is the outcome of the event? resolved.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: 12460409
• MDR Text Key: 271368384
• Report Number: MW5103852
• 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: 03/23/2021
• 3 Devices were Involved in the Event: 1 2 3

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: 09/10/2021
• Patient Sequence Number: 1
• Patient Age: 45 YR