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
One sample was returned for analysis.The sample was connected to a cadd solis pump and water was able to flow trough the entire set with no difficulties and it was successfully primed.Other analysis due to the fact there was no lots for p/n 21-7339-24 was programed to be manufactures in the near future, per previous complaint a review of the manufacturing process for p/n 21-7383-24 l/n 3939051 was conducted by quality engineer on 13-feb-2020, in order to verify that there are no situations or practices that could create the event as described in "complaint description" section.Mitigation during the manufacturing process, production personnel do a visual inspection before a process (assemble, bond, etc.) to ensure that the material is in perfect shape; also right after a work station, personnel redo an inspection in order to find any discrepancies.Production performs a leak and accuracy test to 4 units at shift start up, the end of every shift, the beginning of every job, the end of every job; a new lot of materials/components or equipment adjustment.Quality personnel inspects samples 15 units every 2 hours to ensure that the bonded joints following the criteria below the bonded joints following the criteria below: -tubes are not kinked or coiled too tightly.Tubes shall not have flat spots, or other damage.-parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.-leak test is properly performed.Root cause root cause cannot be determined since the complaint was not confirmed due to the fact the sample was successfully tested.Action taken no corrective actions are required since the complaint was not confirmed.However production personnel was notified by quality engineer on 12-nov-2018 as awareness of the defect reported by the customer.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10190240
• Report Number: 3012307300-2020-06204
• Device Sequence Number: 19041522
• 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): 08/31/2020

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: 12/09/2024
• Device Model Number: 21-7339-24
• Device Lot Number: 3915934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 08/02/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1