MAUDE Adverse Event Report: ST PAUL CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM; PUMP, INFUSION

Model Number	6500
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during the use of the pump "no message" alarm went off.No patient injury was reported.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to a previous repair.Visual inspection found the device in good condition.There was evidence of the error recorded in the event history log.The reported problem was not duplicated during functional test.The investigation was unable to determine the error.It was noted that a possible defective downstream sensor or cassette product could have been the cause of the error.However, no fault was found as the error was not duplicated.For preventive measure the downstream sensor and the upstream sensor were replaced and re-calibration.The root cause of the reported problem was undetermined/unknown.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The device was manufactured in september 2011, and is out of warranty therefore, no manufacturing dhr review is needed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: correction: h4: mfg.Date.11-nov-2022; corrections: d4: model number 6500.

• Brand Name: CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14682133
• Report Number: 3012307300-2022-11749
• Device Sequence Number: 12166833
• Product Code: FRN
• UDI-Device Identifier: 10610586022593
• UDI-Public: 10610586022593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: Other
• Device Model Number: 6500
• Device Catalogue Number: 21-6500-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2011
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown