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

Model Number 7400

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Pt reports woke up to an alarm/ beeping of pump due to "blockage detected" starting at 4:13am pt's local time.Assisted pt and husband with troubleshooting.They checked the tubing for any kinks/ blockages, checked proper insertion of cannula, instructed pt/ husband to replace tubing.Upon tubing replacement, pump began to work again without any issues.Pt does have a nurse coming to visit on friday (b)(6) 2022 and will ask to go over all troubleshooting options for any possible issues in the future.Did the reported product fault occur while in use? yes; did the product issue cause or contribute to injury? no; is the actual device available for investigation? no; did we [mfr] replace device? no; did the patient have a backup device they were able to switch to? not needed, pump now functional.Pump serial number and tubing lot number unk.Not provided by pt.Reported to (b)(6) by pt/caregiver.

• Brand Name: TUBING EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13500407
• MDR Text Key: 285460055
• Report Number: MW5107338
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female