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

Model Number 6400

Device Problem Battery Problem (2885)

Patient Problems Dyspnea (1816); Pain (1994); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported that the patient experienced shortness of breath, fainting and sickle cell pain from stress.The patient woke up in the middle of the night and noticed her pump was not pumping.She stated that she felt faint and passed out.The patient was taken by ambulance in the hospital where she was hospitalized for 4 days.The patient believes that the batteries were drained and caused the pump to shut off without an alarm.The central line was changed during hospitalization.The patient stated that she feels much better now.

Manufacturer Narrative

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 user issue, 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 d3, g1,g2 email is: (b)(6), b3: unknown, a1 updated.

• Brand Name: CADD-LEGACY 1 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: 16139535
• MDR Text Key: 307108472
• Report Number: 3012307300-2023-00368
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• 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 Outcome(s): Hospitalization
• Patient Sex: Female