MAUDE Adverse Event Report: ST PAUL CADD-MS3 INFUSION PUMP; CARTRIDGE; PUMP, INFUSION

Model Number	21-7450-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient woke up to her pump alarming and she was able to troubleshoot the issue by changing the pump and using a new cartridge.The patient stated that the pumps are functioning fine and that once in a while, she will have an issue with malfunctioning cartridge.The product issue did not cause or contribute to patient or clinical injury.
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.Operator of device is unknown.No information has been provided to date.
Event or Problem Description
Additional information was received by the manufacturer on 15-dec-2022 via email and attached to the complaint object.The date of event and patient identifier information has been received and updated into the file.The reported event did occur while in use with a patient.The event did not result in any patient harm and no medical intervention was required.The issue is now reported as resolved.
Additional Manufacturer Narrative
A2: age at time of event: updated with additional information received.A3: sex: updated with additional information received.B3: date of event: updated with additional information received.B5: describe event or problem: updated with additional information received.H6: event problem and evaluation codes: updates are not required.No sample has been received by manufacturing to date.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.
Additional Manufacturer Narrative
No product was returned therefore, no visual or functional evaluation can be performed.We are unable to confirm the reported complaint as no sample was received for investigation.Root cause of the reported event is unknown and cannot be determined as no sample was received.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Corrected data: g3: correction: report source: other / mw5113501.

• Brand Name: CADD-MS3 INFUSION PUMP; CARTRIDGE
• 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; minneapolis, MN 55442
• MDR Report Key: 15951697
• Report Number: 3012307300-2022-27805
• Device Sequence Number: 6419298
• Product Code: FRN
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2022

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
• Device Model Number: 21-7450-24
• Device Catalogue Number: 21-7450-24
• Device Lot Number: 4234936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 12/21/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/22/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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 Age: 53 YR
• Patient Sex: Female