MAUDE Adverse Event Report: NULL CADD CASSETTE RESERVOIRS - 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  

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

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.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 17209229
• MDR Text Key: 317929136
• Report Number: 3012307300-2023-06676
• 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: 04/04/2024

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: 04/04/2024
• 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