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

Device Problems No Audible Alarm (1019); Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the pump is not working properly.Patient put batteries in both pumps right away but stated pumps have not been giving them any alerts, remaining volume has been wrong, and am/pm timing is off.Patient noticed one night that cartridge was empty, but pump never alerted them, and pump stated there was still volume remaining.Patient changed the cartridge because they have been on therapy for a longtime and knew it was about time to change, however they do not know how long the cartridge was empty.Patient reports feeling queasy the next day but didn't think it was related to the pump issue from night before.No other side effects reported.Patient is currently using back-up to successfully continue infusion with no issue.No additional info, details.

Manufacturer Narrative

Other, other text: patient identifiers updated.Initials nb, date of birth (b)(6)1963, gender female.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be the main board not operating as intended, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.D3, g1, and g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD MS3 AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 16636694
• MDR Text Key: 312356029
• Report Number: 3012307300-2023-03189
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

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 Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/07/2023; 12/21/2023
• Supplement Dates FDA Received: 04/12/2023; 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female