MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21710624

Device Problems Use of Device Problem (1670); Defective Device (2588)

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

Event Date 10/09/2021

Event Type  malfunction  

Event Description

Solicited per patient, pump was giving no disposable, pump won't run error on (b)(6) 2021.Patient determined it was the tubing causing the error on the pump.He switched tubing and the error code cleared.He does not have the packing for the defective tubing, so lot number is not known.However, patient does still have the defective tubing.No other information known.Prescriber has not been notified.Did the reported product fault occur while in use with the patient? no; did the product issue cause or contribute to patient or clinical injury? no; is the supply available for investigation? yes; did we replace the supply? no; patient had extra on hand.Did the patient have backup supply he was able to switch to? yes; was the patient able to successfully continue infusion? yes; is the infusion life-sustaining? yes; outcome? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12672600
• MDR Text Key: 278082535
• Report Number: MW5104822
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21710624
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR