MAUDE Adverse Event Report: ST PAUL CADD

Model Number 21-7394-24

Device Problems Volume Accuracy Problem (1675); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that while using cadd administration sets - flow stop an internal volume check was performed and an under-delivery variance of 8% - 15% was noted.There was no patient involved.

Manufacturer Narrative

Other, eight cadd administration sets were returned for analysis.Upon visual inspection, no damages were observed but the arch height pump tube was found low.The samples were set for accuracy testing using a pump solis vip; all samples failed the testing.The manufacturing process was reviewed; no discrepancies found.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10148733
• MDR Text Key: 194966274
• Report Number: 3012307300-2020-05851
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7394-24
• Device Lot Number: 3891136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1