MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7023-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that an unknown alarm occurred to a smiths medical cadd® ambulatory infusion pump.The cassette was changed out with no further problems.No adverse effects were reported.
Additional Manufacturer Narrative
One smiths medical cadd® administration set was returned for analysis in unused conditions inside a plastic bag with it original opened packaging.No abnormality was detected upon visual exam.The cassette was connected and fully primed without difficulties, the pump was set running and the alarm was not activated.Relevant documents were reviewed and deemed adequate.A review of the manufacturing process was conducted.Operations were reviewed with no discrepancies found: the rra assembly operation; training records were reviewed on the pm-297 "ay, admin set, std volume" operation, operators are trained; the test record are within specification; all the calibrations dates of the test equipment are within due date.A sample of 32 units was taken in order to perform a visual inspection with no discrepancies noted.Four samples were accuracy tested from the inventory with no discrepancies detected.Based on the evidence, no root cause was determined as the complaint was not confirmed.

• Brand Name: CADD® MEDICATION CASSETTE RESERVOIR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7355579
• Report Number: 3012307300-2018-00649
• Device Sequence Number: 11067843
• Product Code: FPA
• UDI-Device Identifier: 10610586019821
• UDI-Public: 10610586019821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/16/2018

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: 05/24/2022
• Device Catalogue Number: 21-7023-24
• Device Lot Number: 47X344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 06/17/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1