MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 AMBULATORY INFUSION SYSTEM; PUMP, INFUSION

Device Problems Device Alarm System (1012); Pumping Stopped (1503); No Flow (2991)

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

Event Type  malfunction  

Event Description

It was reported that the pump stopped working overnight.The patient woke up and was pale.It is unknown what time the infusion stopped or how long the patient was without medication.Patient could not hear beeping.The patients daughter stated that the pump was beeping and said stop on the screen.No other messages were displayed.The patient was able to switch to the backup pump and continue infusion.No other patient symptoms were reported.The reported product fault occurs while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.No additional information available.

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: additional information provided in a2 and a3.The item is not available for return.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause is the downstream occlusion sensor; however, this cannot be confirmed as no product was returned for investigation.No serial number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD LEGACY 1 AMBULATORY INFUSION SYSTEM
• 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: 16324646
• MDR Text Key: 309058680
• Report Number: 3012307300-2023-01009
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• 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
• Patient Age: 41 YR
• Patient Sex: Female