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

Model Number 6300

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem 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.D4 and g5 are unknown.No product information has been provided to date.Operator of device is unknown.

Event Description

It was reported that the pump delivered an overdose of medication.No patient injury was reported.

Manufacturer Narrative

Other, other text: device evaluation: a sample was returned to manufacturing for investigation.Visual inspection and functional testing were performed.The pump was repaired by the german service center prior to it being aware there was a complaint against it, however the repair notes indicate the pump problem ?per email: provided too large volume" was not confirmed.The pump was found to be operating properly and passed all tests after the service was completed.The device has not been in for service/repair at mmuc before.

Manufacturer Narrative

Updated h6: health effects - health impact.D3, g1, g2 email address: (b)(6)., corrected data: h10: service history review identified the complaint was not related to a previous service of the device within the review period.

• Brand Name: CADD LEGACY PCA PUMPS
• Type of Device: PUMP, INFUSION PCA
• 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: jim vegel ; 6000 nathan lane north; postboks 93 kjelsas; minneapolis, MN 55442
• MDR Report Key: 16052945
• MDR Text Key: 308262819
• Report Number: 3012307300-2022-28167
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

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 Model Number: 6300
• Device Catalogue Number: 21-6300-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/07/2023; 01/24/2024
• Supplement Dates FDA Received: 03/10/2023; 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1