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

Model Number	7333
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical, admin set didn't deliver correct amount of fluid.The pump was supposed to deliver 1000ml but when the infusion was done it still was about 500ml left in the bag.Bio agnes did an accuracy test with the same pump and 21.7333-24 and 21-7033.24 with major variation.The specific admin set 21-2333-24 delivered 27ml of 50 ml and the 21-7033-24 did deliver 49ml of 50 ml.No adverse patient effects were reported.
Additional Manufacturer Narrative
The samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination according md01-003.No obstructions nor other workmanship defects were detected in none of the joins of the product, only a kink was detected on the pump tube in both samples caused by the ffp system since that it was returned without the blue clip.The samples were set for accuracy testing using a pump solis vip [cal.Id: 1.0273; due date: november 2020] and a balance mettler toledo [cal.Id: 35.0019; due date: january, 2021] to look for unusual function.No discrepancies were detected, test successfully passed (see results on attachments tab disposable accuracy test report).No fault was found with the returned sample.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10121872
• Report Number: 3012307300-2020-05501
• Device Sequence Number: 11662624
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 08/23/2024
• Device Model Number: 7333
• Device Catalogue Number: 21-7333-24
• Device Lot Number: 3860299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1