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

Device Problems Power Problem (3010); Intermittent Loss of Power (4016); Unexpected Shutdown (4019)

Patient Problem Syncope/Fainting (4411)

Event Type  malfunction  

Event Description

It was reported the pump stopped about 4 hours ago.Previously the pump stopped for 8 hours and when she restarted the pump she felt like she may faint.No further details provided.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Health impact and evaluation codes: updated device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The most probable cause was the circuit board.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16315458
• MDR Text Key: 309022139
• Report Number: 3012307300-2023-00984
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• 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
• Patient Weight: 45 KG