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

Lot Number 4327082

Device Problem Pressure Problem (3012)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

Spoke to patient and wife regarding high pressure alarm occurring every few minutes.Patient switched out pumps, tubing, cassette, medication, and flushed their iv line with no success.Patient noted the alarm, started friday night ((b)(6) 2023) when they changed their cassette.Patient's wife noted that they also used the same lot number for the cadd ext sets during that change and while troubleshooting the alarm: (lot: 4327082).Advised patient/wife to use different lot number that they had available [4303046, 4282465).Upon change, alarm was resolved.Placed refill order for supplies used while troubleshooting and replace affected lot number for cadd ext sets.No further info.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual product available for investigation? no.Did we [mfr] replace the product? yes.Did the pt have a backup product they were able to switch to? yes.Was the pt able to successfully continue their therapy? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16279004
• MDR Text Key: 308655447
• Report Number: MW5114617
• 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: 01/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4327082
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male