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

Model Number 21-7346-24

Device Problems Volume Accuracy Problem (1675); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

Per complaint: this is the 3rd time within a month that i encountered this issue, where a patient was connected to a cadd solis vip 2120 pump, with the administration set, and although the pump indicates all of the medication bag was given, there was still a significant amount of medication left.I can give you the tubing, but not the pump.The pump is owned by mckesson.I have a suspicion that there?s an issue with the tubing.We ran two tests with this tubing by running the pump and collecting the fluid.Then did another two tests using brand new tubing and the same pump.There was a significant difference in volume collected between the patient tubing and the brand new tubing.Unfortunately, i don?t know the lot number of the tubing.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11868236
• MDR Text Key: 252137772
• Report Number: 3012307300-2021-04768
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1