MAUDE Adverse Event Report: NULL CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem Pulmonary Hypertension (4460)

Event Date 11/18/2022

Event Type  Death  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

Information was received via attorney communication that a patient passed away due to pulmonary hypertension.Patient was receiving veletri via "cadd products" pursuant to physician's orders for "life-saving treatment of pulmonary hypertension resulting from a covid diagnosis in 2021." it was reported that following the patient's death, the family received a "correction letter" from smiths medical related to the lot numbers the patient was using prior to her passing.Information was received that there is a belief that the products could have been a factor in the patient's passing.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.No lot number was provided; therefore, a history record review could not be conducted.If the product is returned this complaint will be reopened for further investigation.G1, email address: (b)(6).

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 17209336
• MDR Text Key: 317928884
• Report Number: 3012307300-2023-06677
• Device Sequence Number: 1
• Product Code: FPA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/05/2024
• 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
• Patient Outcome(s): Death
• Patient Age: 22 YR