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

Device Problem Priming Problem (4040)

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

Event Type  malfunction  

Event Description

Unsolicited communication: pt reports her pump (serial number (b)(4)) was alarming high pressure as she was trying to prime new cassette with that pump.(pt was only trying to prime, she was attached to her current pump and no stop in infusion) she stopped the alarm but it kept ringing.Pt advised high pressure may be due to kink in fluid path, or a close tubing damp etc, but pt advised she did not close tubing clamp, etc.Pt advised then to change out the tubing to see if that works and patient put rph on hold and tried.Pump no longer has error message of high pressure after adding new tubing.Pt does not have lot number of tubing.Pt advised to keep on the side incase it is needed.No further questions.Pt did not have pump malfunction.It was her tubing issue.No further information is known.All known information is contained on this form.If any additional information is received it will be provided on a separate report.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did the pt have a backup device they were able to switch to? yes; pt had backup tubing; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to cvs/caremark 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: 14601618
• MDR Text Key: 293522090
• Report Number: MW5110100
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2022
• Patient Sequence Number: 1
• Treatment: INFUSION PUMP
• Patient Sex: Female