MAUDE Adverse Event Report: ST PAUL CADD; INFUSION PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Diarrhea (1811); Swelling/ Edema (4577)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Model number was not provided and is unknown.510k number was not provided and is unknown.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that a pharmacist spoke to patient to get an update on hospitalization that was previously reported on (b)(6) 2021.Patient was admitted to the hospital on (b)(6)2021.He was there for 3 or 4 days.Patient was admitted due to diarrhea and significant swelling on his ankles.He was on remodulin subcutaneous with cadd ms3 pump.Patient's remodulin dose has been lowered.No other information known.

• Brand Name: CADD
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16741983
• MDR Text Key: 313305100
• Report Number: 3012307300-2023-04124
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male