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

Catalog Number 21-6300-51

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

Event Description

It was reported the device exhibited an upstream occlusion alarm.Tubing assessed for occlusion and there was no occlusion.Spike was fully inserted in medication bag.Attempted for several minutes to resolve the occlusion.The alarm persisted.The patient's knee replacement surgery was on (b)(6) 2023.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: 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.

Manufacturer Narrative

Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause of an upstream occlusion alarm is the uso sensor, or kink in the tubing; however, this cannot be confirmed as no product was returned for investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD LEGACY PCA
• 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: 17607054
• MDR Text Key: 321779489
• Report Number: 3012307300-2023-08331
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: 10610586019449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1