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

Device Problem Defective Device (2588)

Patient Problems Dyspnea (1816); Vasodilatation (2127); Lethargy (2560); Balance Problems (4401)

Event Date 11/07/2022

Event Type  Injury  

Event Description

It was reported that the device malfunctioned.Pump stated that it was running but patient passed out three times prior to hospitalization.Patient was symptomatic with shortness of breath, lethargy, pale, cool, syncope, seeing spots, and falling.Upon arrival to hospital the pump was changed to an alternate pump and patient became symptomatic of vasodilation.

Manufacturer Narrative

Unique identifier (udi), lot number, catalog number, operator of device and protocol # are unknown.No information has been provided 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.

Manufacturer Narrative

No product was returned.The reported issue 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.D4: serial number, model number and h4 are unknown, h3 and h6: health effects, health impact updated.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16158400
• MDR Text Key: 307293711
• Report Number: 3012307300-2023-00468
• 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
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2023
• 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 Outcome(s): Hospitalization