MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Device Alarm System (1012)

Patient Problem Underdose (2542)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical cassette was implicated in causing the pump to cause a "no cassette" alarm.The nurse tried to use another pump but the same issue reoccurred.They attempted to clean the cassette but got the same issue.The pump was being used for chemotherapy.The treatment was not fully administered due to this issue.There were no reported adverse events.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing; unable to confirm the reported customer complaint.Pump was set running and alarm was not activated.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10680675
• MDR Text Key: 211426159
• Report Number: 3012307300-2020-10296
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Lot Number: 3926200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 01/17/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1