MAUDE Adverse Event Report: ST PAUL CADD

Model Number 21-7394-24

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that while using cadd administration sets - flow stop an internal volume check was performed and an under-delivery variance of 8% - 15% was noted.There was no patient involved.

Manufacturer Narrative

Other, other text: returned device was received in good physical condition.During the evaluation of the returned samples failed accuracy testing.Other analysis 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 personnel perform a 100% visual inspection in order to verify that the pump tube arch height is within tolerance.Production personnel perform an accuracy test to 4 samples at shift start up, the end of every shift, the beginning of every job, the end of every job; or a new lot of materials/components or equipment adjusted.Quality takes a sample of 15 units at an interval of two (2) hours, prior to placing product in bag, in order to: -inspect pump tube uv bond to housing, in order to verify that the pump tube arch height is within tolerance.-verify that the adhesive not be excessive or outside the defined application area.-verify parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.-audit the accuracy test is being performed according to the manufacturing procedure.Root cause in order to perform a complete root cause analysis of this failure mode, capa 20capa018 was open on 15-oct-2019.Action taken capa 20capa018 was open on 15-oct-2019 in order to implement corrective actions for this failure mode.Additional information: no patient present at the time of the event as this issue occurred during testing.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10151268
• MDR Text Key: 195070413
• Report Number: 3012307300-2020-05876
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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
• Device Operator: No Information
• Device Model Number: 21-7394-24
• Device Lot Number: 3925421
• 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 Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1