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

Model Number	21-7323-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that tazozin was running intermittently at a dose of 159ml/hour for 8 hours with a 500 ml bag.However, there was 54 ml residual at the end of infusion.No patient injury was noted.
Event or Problem Description
(1/2, reference cc-0092262 for all related complaints and attachments) per email: tazozin was running at intermittent dose of 159ml rate 8 hourly with a 500ml bag on the 14.10 and there was a 54ml residual.No injury.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.Visual inspection was done with no damages were detected on the sample; however arch height pump tube looks low.Functional testing done setting up pump line and pump did not pass accuracy testing.A capa was formed to correct this issue.In order to perform a complete root cause analysis of this failure mode, capa-(b)(6) was open on (b)(6) 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: 10893103
• Report Number: 3012307300-2020-11712
• Device Sequence Number: 2895554
• 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,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 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: 10/26/2020
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 11/24/2020
• 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