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

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the pump alarmed 'no disposable- clamp tubing.'upon restart, pump alarmed no disposable pump will not run.' settings reviewed, pump turned off, and tubing clamped.Cassette removed and tubing massaged while pressing green flow stop down.Air bubbles were present in the cassette tubing.Cassette was tapped on a hard surface and attached.Pump turned on, settings reviewed and upon restart, alarm returns.Process repeated and alarm persisted.Patient not affected.No patient injury reported.

Manufacturer Narrative

Device identification (udi) is unknown; no further information was provided.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16440556
• MDR Text Key: 310252976
• Report Number: 3012307300-2023-01685
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1