MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, 105", SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7024
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that an administration set connected to a smiths medical cadd infusion pump caused an upstream occlusion alarm.It was noted that the cartridge was difficult to attach to the pump.The infusion was not life sustaining.There were no adverse events reported.
Additional Manufacturer Narrative
Device evaluation: one cadd cassette reservoirs was returned for analysis.The sample consist of one product from p/n 21-7024-24 l/n 3857625; the returned sample was received in used conditions inside a plastic bag without its original packaging.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination and found the sample with both of the star tube detached from the housing.According to the investigation this is due to the solvent being enough, but the location was not correct.Functional testing on the sample received was performed using a cadd solis pump to look for unusual functions.According to the investigation, it was difficult closing the pump with the star tube detached, and it was necessary accommodate the right position to avoid squash the star tube.The customer's reported problem was confirmed.According to the investigation, the most probable root cause is that production personnel did not detect that adhesive in proper position during manufacturing.In order to address the possible causes, quality engineer assigned magnifying lamps to production line for better visual inspection of the adhesive.The problem source of the reported problem is manufacturing.

• Brand Name: SET, ADMIN, CADD, 105", SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9728485
• Report Number: 3012307300-2020-01403
• Device Sequence Number: 2474485
• Product Code: FPA
• UDI-Device Identifier: 10610586019852
• UDI-Public: 10610586019852
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 08/14/2024
• Device Model Number: 7024
• Device Catalogue Number: 21-7024-24
• Device Lot Number: 3857625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 07/05/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1