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

Model Number	21-7323-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the pump had under infused medication.The program was as follows: 500 mls of 13500 mg of piperacillin was to be infused 159 mls/hour.There should have only been 12.4 ml of the medication left at the end of the infusion, however the residual volume was 60 ml.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: h10 ?device evaluation: the cadd administration set was returned for investigation in used condition.The returned administration set was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.No damages were found.The investigator did note however that the arch height of the tube seemed to be low.The product was tested for accuracy using a cadd legacy pump.The customer reported product problem (under infusion) was confirmed.The product problem was attributed to a manufacturing issue.This was established as the root cause.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10814512
• Report Number: 3012307300-2020-11289
• Device Sequence Number: 17025440
• Product Code: FPA
• UDI-Device Identifier: 10610586039614
• UDI-Public: 10610586039614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 04/20/2025
• Device Model Number: 21-7323-24
• Device Catalogue Number: 21-7323-24
• Device Lot Number: 3971607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1