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

Model Number 6400

Device Problems Crack (1135); Fluid/Blood Leak (1250); Nonstandard Device (1420); Inaccurate Delivery (2339); Obstruction of Flow (2423)

Patient Problems Dizziness (2194); Malaise (2359)

Event Type  Injury  

Event Description

Pt confirmed they have 10 cassettes of lot 4321040 that are affected by recall and 1 cassette of lot 4298336 that are affected.Pt reported had problems with pump since (b)(6) 2022; experienced occlusion and also had alarm going off.Pt reported the blue cap that prevents medication from going back has not worked properly and has led to leakage.There was 1 cassette that had cracked and had to be sent back to the mfr about 2 months ago.Pt sometimes gets feeling of "bolus" where they feel have gotten too much of medication, leading to feeling sick and dizzy.This normally happens when there is only about 50ml of medication left on the cassette.Pt's md ended up increasing the remodulin dose due to having trouble with walking distances, but unsure if it's because of pt condition or due to pump malfunction.Pt is not experiencing any issue with current cassette actively in use right now.Unknown lot number of legacy pump no add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow 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? yes.If yes, was any medical intervention provided? yes.Is the actual product available for investigation? unk.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 LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16272817
• MDR Text Key: 308579859
• Report Number: MW5114587
• Device Sequence Number: 1
• Product Code: LHI
• 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: 12/19/2022
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female