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

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

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi), lot number, catalog number 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.

Event Description

It was reported that the device had a no disposable alarm.Patient went directly to emergency room and changed cassette in the emergency room and pump started working normally.

Manufacturer Narrative

Other, other text: additional information provided in h6 and h10.Device evaluation: a sample was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Sample was received in used conditions without its original packaging.During functional testing, sample was fully priming and connected without difficulty.Pump was running and no alarms were activated.No root cause was determined and no action was taken.No lot/serial number was provided; therefore, a device history record (dhr) review could not be performed.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• 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: 16054782
• MDR Text Key: 306208173
• Report Number: 3012307300-2022-28180
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female