MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Alarm System (1012); Connection Problem (2900)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that the device caused a no disposable alarm.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Unique identifier (udi), lot number, catalog number and 510k number 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 complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned this complaint will be reopened for further investigation.Email address: (b)(6).

• Brand Name: CADD MEDICATION CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16060796
• MDR Text Key: 308382591
• Report Number: 3012307300-2022-28196
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/20/2024

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/20/2024
• 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: 55 YR
• Patient Sex: Female