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

Model Number	21-7383-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that pump had difficulty delivering the infusion during prefilling.Customer notes, "instead of the usual 12-13 ml, it was 40 ml." after 14 hours in use, more than half of the infusion remained in the bag.The problem persisted even after replacing the pump.
Event or Problem Description
Investigation completed.
Additional Manufacturer Narrative
Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop visual inspection completed.Visual inspection done under normal specifications and this revealed arch height pump tube looks low in some of them.Seven samples tested all passed but one sample did not, so report confirmed.Root cause in order to perform a complete root cause analysis of this failure mode, capa-000589 was open on 10-oct-2019, on which root cause states that inadequate process controls for tube arch height and tube placement have allowed pump tubes on cadd disposable to have too low a tube arch and to not be centered.Tight and misaligned pump tubes have resulted in reduced fluid delivery.

• Brand Name: CADD
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10962419
• Report Number: 3012307300-2020-12190
• Device Sequence Number: 19645859
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 03/17/2025
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3955195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1