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

Lot Number 1112968

Device Problem Inaccurate Delivery (2339)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 07/21/2019

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cassette was noted in an over infusion issue.A 100ml cassette was used and after 6 hours, there should be 54.4 ml duopa left in cassette but the cassette was completely empty.The patient was having hallucinations and delusions.It was additionally noted that the patient has a rem disorder and was trying to nap but could not with no duopa being infused.When putting in a new cassette, the patient was able to sleep.When previously using a cassettes with a different lot number, the cassettes were running for about 15-16 hours.After switching to this newer lot number a few weeks ago, and the cassettes were getting empty after 6-7 hours.There were no further adverse events noted.

• Brand Name: CADD INFUSION CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 9687508
• MDR Text Key: 178390743
• Report Number: 3012307300-2020-01134
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1112968
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR