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 text: returned device was received in good physical condition but the arch height pump tube is low.Samples failed accuracy testing confirming the reported issue.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 eve.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.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10148708
• MDR Text Key: 194966155
• Report Number: 3012307300-2020-05850
• 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

• Date FDA Received: 06/12/2020
• 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: 3891136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1