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

Model Number 21-2120-0105-01

Device Problems Pumping Stopped (1503); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  Injury  

Event Description

The patient came in for cadd pump removal from 5fu 46 hour infusion.Cadd pump showed 99.8ml remaining.The patient may have inadvertently stopped the cadd pump.

Event Description

On day one @ 1325, the patient was connected to cadd pump #3 which was programmed to infuse 5fu 3790mg/100ml over 46hours.Prior to sending the patient home with the pump, it was verified by two rns that the pump was running and infusing.On third day the patient returned to the hospital to return the cadd pump.Rn was going to disconnect the patient from the pump when she noticed 99.7ml was remaining to infuse (0.3ml-infused).The cadd pump had been stopped.Md was notified, as well as the pharmacy.The physician placed another order for 5fu 3790mg/100ml, pharmacy mixed the chemotherapy and provided a new cassette to attach to the cadd pump.Rn connected the cassette with the 5fu to cadd pump #4.The patient returned to the hospital after two days with cadd pump#4, 5fu infused completely.Cadd pump #3 was sent to biomed.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 15671484
• MDR Text Key: 302401396
• Report Number: 15671484
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-2120-0105-01
• Device Catalogue Number: 21-2120-0105-01
• Device Lot Number: 1219814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2022
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic