MAUDE Adverse Event Report: ST PAUL CADD

Model Number	21-7339-24
Medical Device Problem Codes	Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that cadd administration sets - flow stop is not able to be primed.The pump indicates that 10 cc was primed.There's also suspicion that the tube is leaking.The infusion was for ropivacaine and fentanyl.There were no adverse events reported.
Additional Manufacturer Narrative
Evaluation results: one cadd administration set was returned for investigation.The sample was primed using a cadd solis pump.The priming was successfully completed without any issues.Water flowed through the entirety of the set.A leak test was also performed.No leaks were found.No fault was found with the returned device.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10190218
• Report Number: 3012307300-2020-06203
• Device Sequence Number: 835920
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (Y/N): N
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: No Information
• Device Expiration Date: 03/03/2025
• Device Model Number: 21-7339-24
• Device Lot Number: 3949549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1