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

Device Problem Improper Flow or Infusion (2954)

Patient Problem Underdose (2542)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The type of pump and serial is currently unknown.

Event Description

Information was received indicating that the cadd pump malfunctioned.It was reported that there's 12-18% residual chemo dose left behind in the pump when administering 5-fluorouracil (5fu).Additional information received provided that for a dose of 4920mg and a volume 98.4ml, the residual volume measured was 13ml, percent of residual dose 13%.There were no adverse events reported.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• 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; travis afb; minneapolis, MN 55442
• MDR Report Key: 10492278
• MDR Text Key: 205622068
• Report Number: 3012307300-2020-09039
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• 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 Weight: 83