MAUDE Adverse Event Report: ST PAUL CADD MS3 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 7400

Device Problems Device Alarm System (1012); Material Fragmentation (1261); Device Fell (4014)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the device was dropped and was alarming.The black cartridge cap is chipped.Patient reported when changes site has pain in arms.

Manufacturer Narrative

D5 is unknown.No information has been provided to date.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

No product was returned.The investigation determined the most probable cause to be damage caused by customer dropping the pump, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.As the device was beyond a year from the manufacture date and with no indication of a manufacturing defect, no device history review was performed.Per service history review this device has not been in for service previously., corrected data: h6 health effects codes.

• Brand Name: CADD MS3 AMBULATORY INFUSION PUMP
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15874953
• MDR Text Key: 307666266
• Report Number: 3012307300-2022-27550
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: 10610586029554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 68 KG