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

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); No Flow (2991)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4:udi section is unknown, no product 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.

Event Description

It was reported that the pump stopped infusing while in use with a patient.When the pump was opened up, the medication leaked out and the pump would no longer work.It was also reported that it was difficult to attach cartridges to the pump and they were either too tight and hard to remove or too loose and medicine leaked out.Fault occurred while in use with the patient but no patient injury was reported.

Manufacturer Narrative

Additional information is provided for h.2 and h.6.No product was returned.The investigation determined the most probable cause to be due to the cartridge and tubing connections not being sufficiently tightened or the specific cartridge having a leak, 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.No serial number was provided; therefore, a history record review could not be conducted.G1, email address: regulatory.Responses@icumed.Com.

Manufacturer Narrative

Device not returned.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17776433
• MDR Text Key: 323762394
• Report Number: 3012307300-2023-09047
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1