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

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital due to the pump not delivery medication.It was unknown if there were any adverse patient effects.

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.B3, d4: model number, catalog number, serial number, udi, g5, and h4 are unknown.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause for the symptoms is due to the pump being improperly programmed; or component(s) not operating as intended because of unintentional damage, 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.Email address: 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: jim vegel
• MDR Report Key: 18165662
• MDR Text Key: 328480441
• Report Number: 3012307300-2023-10608
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• 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 Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 74 KG