MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported the infusion completed but the bag was still full.The event log was analyzed and could not find anything out of the ordinary.Bench testing the pump found no issues.No patient injury was reported.

Manufacturer Narrative

Catalog number is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Premarket (510k) number is unknown.Operator of device is patient/consumer.Initial reporter also sent report to fda is 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.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP
• 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: 15322197
• MDR Text Key: 301011493
• Report Number: 3012307300-2022-08843
• 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
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male