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

Model Number 21-6300-51

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical was noticeably leaking, and would begin pumping excessively over 30-45 second period without the dose button being pressed.The patient indicated at one point that the pump mechanism woke him, and his wife up from sleeping.The patient used feminine hygiene products to absorb the leakage and the patient was experiencing some relief, which is why he continued to have the pump infuse to the end.There were no reported adverse events.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10740109
• MDR Text Key: 213189271
• Report Number: 3012307300-2020-10632
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-6300-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1