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

Lot Number 4052410

Device Problems Device Alarm System (1012); Defective Device (2588)

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

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Spontaneous call.Patient called with 'no disposable' alert on both the main pump and back up pump.Advised patient that highly unlikely that both pumps would have the same problem.Instructed patient to mix a new solution with a new cassette with a different lot number.Patient did as instructed.No more alarms.Defective cassette: 4052410.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? yes.Did we replace the device? no.Did the patient have a back up 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.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSTTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12467238
• MDR Text Key: 271656458
• Report Number: MW5103903
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4052410
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR