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

Lot Number 4157445

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Spontaneous call from patient to report faulty cassette.Patient states he had no disposable alarm on cadd legacy pump.He went to back up pump with same cassette and had same error message.He mixed a new cassette and error resolved.No interruptions in therapy or adverse events resulted.Cassette is available for investigation.Error occurred while in use with the patient.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 [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? 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.; minneapolis MN
• MDR Report Key: 12681764
• MDR Text Key: 278158214
• Report Number: MW5104853
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4157445
• 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