MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Defective Device (2588)

Patient Problems Arrhythmia (1721); Dyspnea (1816)

Event Type  Injury  

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.

Event Description

It was reported that there was an unknown issue with the device resulting in the patient having shortness of breath.Patient was using oxygen prior to being hospitalized for 10 days.No patient injury was reported.

Manufacturer Narrative

Other, other text: additional information in h6 (evaluation codes) and h10.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined., corrected data: correction provided in h1 (serious injury) and h6 (shortness of breath).

• Brand Name: CADD CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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; minneapolis, MN 55442
• MDR Report Key: 16250822
• MDR Text Key: 308463117
• Report Number: 3012307300-2023-00700
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4329615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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