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

Model Number	21-7383-24
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set caused the cadd solis vip pump to alarm "air bubble" in the middle of the night during a parenteral nutrition infusion.This occurred 13 different times between (b)(6) 2020 with 6 different patients and varying lot numbers of cadd administration sets.Various nutrition such as "olimel n7 smothkabiven, clinimix, perikabiven, cernevit, and nutryelt" were being infused during these reported events.The duration of infusions were set to 15 hours.This tubing was connected to port cath ( implantable port) or via the jugular vein.The pumps used during the incident were new.The user noticed the bubbles were microbubbles or large bubbles and then these bubbles stagnated.A flush of the tubing was systematically conducted after the incident.There was no reported adverse event or injury.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set was returned for analysis.During functional testing it was noted that the sample was received connected to pump solis vip to prime the device; the pump was set running and no alarm was activated, however a leak was detected fleeing from the air vent of the filter.Based on the evidence, the complaint was not confirmed, and no fault was found regarding the reported issue.

• 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: 10375003
• Report Number: 3012307300-2020-07895
• Device Sequence Number: 2888826
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (Y/N): N
• PMA/510(K) Number: K040899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: No Information
• Device Expiration Date: 01/15/2025
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3925418
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1