MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE RESERVOIR, 50ML; PUMP, INFUSION

Catalog Number	21-7001-24
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: year of event have been provided, but month and day is unknown.D4 - lot #: possible lot number: 43491 h3: neither samples nor pictures were received for analysis."no device history record was reviewed since lot number was not found in mtij system." without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that during infusion the device for no apparent reason started to alarm ¿cassette is not set correctly¿.Per reporter, this happened on 3-9 occasions.The exact dates are unknown, but they have happened in a time period of (b)(6) 2024.The device was checked several times by a biomedic and passed the annual check well.Possible lot number provided:43491.There was patient involvement.

• Brand Name: CADD CASSETTE RESERVOIR, 50ML
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21233480
• Report Number: 3012307300-2025-01088
• Device Sequence Number: 8630015
• Product Code: FRN
• UDI-Device Identifier: 10610586022111
• UDI-Public: (01)10610586022111
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K843772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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 Catalogue Number: 21-7001-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown