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

Model Number 6400

Device Problem Connection Problem (2900)

Patient Problems Muscle Weakness (1967); Syncope/Fainting (4411); Swelling/ Edema (4577)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.No lot number provided for dhr.

Event Description

It was reported that a cadd legacy pump alarmed, and the patient switched to new cassette prior to calling ncsc.Patient reportedly awoke to her cadd legacy pump alarming "no disposable" at 2:30 am.She was lethargic and short of breath.After calling accredo, she fainted and the call disconnected.Feeling better now but is still weak and her knee is swollen from the fall.Serial numbers for last pumps sent to patient are (b)(4).

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• 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: jim vegel ; 6000 nathan lane north; suite 100; minneapolis, MN 55442
• MDR Report Key: 14553136
• MDR Text Key: 293466981
• Report Number: 3012307300-2022-10227
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• 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