MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PUMP; PUMP, INFUSION

Model Number 6400

Device Problem Pumping Problem (3016)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous communication from (b)(6) from (b)(6) hospital emergency room to report patient is currently in the hospital due to a pump malfunction regarding which no other information is available.Date of admission, projected length of stay, and anticipated discharge date unknown at time of call.Pump serial number and due date unknown.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unknown.Position of pump when event occurred is not known.No additional information is available at this time.Did the reported product fault occur while in use with the pt? unk.Did the product issue cause or contribute to pt or clinical injury? hospitalization; if yes, was any medical intervention provided? yes.Is the actual product available for investigation? unk.Did we mfr replace the product? no.Did the pt have a backup product they were able to switch to? unk.Was the pt able to successfully continue their therapy? yes.Reported to (b)(6) by health professional.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16113256
• MDR Text Key: 306905418
• Report Number: MW5114204
• Device Sequence Number: 1
• Product Code: FRN
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTENSION SET ; TREPROSTINIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Female