MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION

Model Number 21-7106-24

Device Problems Device Alarm System (1012); Deformation Due to Compressive Stress (2889)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Two pictures were received for evaluation from the user.From the pictures, no anomalies or discrepancies could be seen on the product.Other analysis: a review of the manufacturing process for p/n 21-7302-24 l/n 4019429 was conducted by quality engineer on 31/jul/2020, in order to verify that there are no situations or practices that could create the event as described in complaint description section.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp requirements and shm procedures: accuracy test was reviewed in three (3) units, in order to verify that no alarms were activated; no discrepancies were found.A review of the production floor was conducted, a sample of 32 units were taken in order to verify for occlusions, kinked tubing and that the bags were correctly placed; no discrepancies were detected.Mitigation: production performs a 100% in process inspection, in order to verify for occlusions, kinked tubing verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Production performs an accuracy test; takes a sample of (3) parts at shift start-up, beginning of every job; at least every (5) hours.Quality takes a sample of 15 units at an interval of two (2) hours +/-30 minutes, prior to placing product in bag, in order to verify for occlusions, kinked tubing and verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Quality verifies that the accuracy test is been correctly performed.

Event Description

Information was received indicating that a smiths medical disposable was thought to be causing the pump to beep.It is believed that the beeping is related to the disposable lines or cassettes as they occurred with one batch and not the other.In addition, some kinks were found in the line and it looked like the tubing at the top of the cassettes were crooked.The issue was resolved by using a different batch of cassettes and lines.There were no reported adverse events.

Manufacturer Narrative

Two pictures were received for evaluation.The pictures showed a pinch mark in the extension tube.It was determined that the most probable root causes were that the clamp was activated during the manufacturing process and originated the pinch marks in the tube, or the damage of the tube occurred after the product left the manufacturing facility.A device history record (dhr) review was performed and indicated all inspections were completed and no issues were noted during manufacture.The reported problem was confirmed and the problem source was determined to be manufacturing.Additional information b4, g1, g4, g7, h2, and h6.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4)., corrected data: correction h3 and h10.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10394287
• MDR Text Key: 202501632
• Report Number: 3012307300-2020-08065
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7106-24
• Device Lot Number: 3656186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female