MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. SET, ADMIN, CADD, SPIKE, 0.2 FLTR, COILED TUBE, ADD-ON ASV, BLUE STRIPE 15/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7036-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set spike 0.2 fltr coiled tube blue stripe pump was alarming cassette not attached.Resource line directed on the phone how to resolve issue and steps were implemented, including changing batteries.Cadd pump was exchanged and the same cassette was reattached with no resolving issue.Changed to a new cassette on the new pump and issue resolved.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set (part number 21-7036-01, lot number 3745717) was returned in used condition without its original packaging.Visual inspection showed no discrepancies.Functional testing involved connecting the sample to a cadd solis pump and showed that when the pump was set to run, no alarm occurred.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: SET, ADMIN, CADD, SPIKE, 0.2 FLTR, COILED TUBE, ADD-ON ASV, BLUE STRIPE 15/BX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8874757
• Report Number: 3012307300-2019-03980
• Device Sequence Number: 16778343
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• 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): 09/25/2019

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: 01/24/2024
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3745717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1