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

Model Number 2120

Device Problem Intermittent Loss of Power (4016)

Patient Problem Underdose (2542)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pump was turning off and on several different times and the patient only received 5 hours worth of a 28 hour treatment on blincyto.The patient was pull off this treatment as a result of this error.There were no other reported issues.

• 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; minneapolis, MN 55442
• MDR Report Key: 10589813
• MDR Text Key: 208633049
• Report Number: 3012307300-2020-09845
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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