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

Device Problems Device Alarm System (1012); Obstruction of Flow (2423)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported that one pump (serial number unavailable as she was not at home) gave multiple occlusion alarms this past week, so changed sites twice and moved to back up pump.It was reported that during these site changes and pump issues, patient experienced headaches, nausea, and vomiting and said she also had a head cold.Last site change (b)(6) 23.She said medical doctor is aware of site issues (now only last 2 weeks at a time).Photographs were not provided.This is a continuous infusion.No additional information is available at this time.The reported product fault occur while in use with a patient.The product issue cause or contribute to patient or clinical injury.The actual device is available to be returned for investigation.

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

Other, other text: no product was returned.The investigation determined the most probable cause to be the dso sensor, 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.A1 updated, d4: udi, catalog number, model number, g5, and h4 are unknown d3, g1, and g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD MS3 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: 16794811
• MDR Text Key: 313814219
• Report Number: 3012307300-2023-04417
• 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 Health Care Professional
• Type of Report: Initial,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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/19/2024
• 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 Age: 72 YR
• Patient Sex: Female