MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PLUS PUMP; PUMP, INFUSION

Model Number	6500
Medical Device Problem Codes	Failure to Sense (1559); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during use of this smiths medical cadd legacy plus pump, the pump exhibited "no disposable detected" alarm after connecting cassette to pump.No patient injury reported.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Additional Manufacturer Narrative
Other, other text: additional information: h6 and h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.Visual and functional testing was performed.The labels were undamaged.The device was found in good condition, no physical damage was found on the pump.The event history log (ehl) shows "no disposable" alarm messages.The customer reported issue could not be duplicated at time of investigation.No problems were found with the pump displaying "no disposable" (no cassette) messages when an undamaged cassette was properly attached to the pump.The pump was found to be operating properly and passed all tests.The root cause remains undetermined., corrected data: correction: h6 and h10.

• Brand Name: CADD LEGACY PLUS PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12957289
• Report Number: 3012307300-2021-12414
• Device Sequence Number: 16607958
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: Lay User/Patient
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 04/27/2023
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/07/2022; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male