MAUDE Adverse Event Report: ST PAUL CADD

Model Number	21-7059-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient arrived to infusion center.He turned the pump off because of an alarm (unknown at this time).The bag appeared to be empty so he turned off the pump and went to infusion center.Pump was to infuse over 120 hours and when he arrived to clinic there should have been 13.5 hours remaining.Erica, rn stated that there was not 47.9 ml in the bag and the bag was in fact empty.Medication: 5fu.Settings at start of infusion: 500ml to be infused at 4.2 ml/h over 120 hours.Settings upon return to clinic: res vol: 47.9ml, rate: 4.2ml/h, given: 450.45ml.Programming verified.Greater than 6% discrepancy.No overfill is added to bag.Cadd set 21-7059-24 lot# 4080929.No further information available.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11942418
• Report Number: 3012307300-2021-05514
• Device Sequence Number: 13783250
• Product Code: FPA
• UDI-Device Identifier: 10610586020421
• UDI-Public: 10610586020421
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K990083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2025
• Device Model Number: 21-7059-24
• Device Catalogue Number: 21-7059-24
• Device Lot Number: 4080929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1