MAUDE Adverse Event Report: ST PAUL CADD LEGACY PCA AMBULATORY INFUSION SYSTEM; PUMP, INFUSION

Model Number 21-6300-02

Device Problems Failure to Sense (1559); Defective Component (2292)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.

Event Description

It was reported, a problem with the air sensor on the side.This is because the plastic shell on the side is worn.And this leads to malfunction when the customer wants to pinch the tubing.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: b3: unknown; no information has been provided to date.Device evaluation: one device was returned for analysis in used condition.Visual inspection showed the tamper seal was missing.The pump was observed to be in good condition with no physical damage found.Review of the event history log showed occurrences of "air in line detected" alarm messages.Functional testing was not able to duplicate the reported issue.The air detector was found to be operating properly, no issues were found.Service history review identified the complaint was not related to a previous service of the device within the review period., corrected data: h6: health effects.

• Brand Name: CADD LEGACY PCA AMBULATORY INFUSION SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17300518
• MDR Text Key: 318847867
• Report Number: 3012307300-2023-07104
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: 10610586019357
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-6300-02
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/29/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1