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

Lot Number 4108674

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

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

Event Date 05/30/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient's husband who reports he is changing the cassette and tubing and got a high-pressure alarm.Spouse confirmed that all damps were open and there were no kinks in the line.Discussed with spouse that he could try back up pump and see if the same thing happened or try a new tubing.Spouse connected a new tubing set and was able to continue infusion with no issue.Serial# (b)(4); 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? no; did we replace device? no; 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.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 12672617
• MDR Text Key: 278081871
• Report Number: MW5104825
• 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: 05/30/2021

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: Lay User/Patient
• Device Lot Number: 4108674
• 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
• Patient Age: 57 YR