MAUDE Adverse Event Report: CAREFUSION, INC THORA-PARA VALVED (TPT)

Catalog Number PMCF SURVEY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Liver Laceration(s) (1955); Pneumothorax (2012); Pulmonary Edema (2020); Pleural Empyema (4459); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Pr (b)(4) follow-up emdr for device evaluation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that re-expansion pulmonary edema ¿ 50, pneumothorax -40, hemothorax ¿ 20, laceration of lung or lever ¿ 40, hypotension/circulatory collapse ¿ 100, infection following thoracentesis ¿ 100, empyema and infection in the pleural cavity ¿ 100, bleeding from peritoneal site ¿ 100, post-paracentesis circulatory dysfunction - 100, thora-para valved (tpt) catheter drainage system.Re-expansion pulmonary edema ¿ 50, pneumothorax -40, hemothorax ¿ 20, laceration of lung or lever ¿ 40, hypotension/circulatory collapse ¿ 100 , infection following thoracentesis ¿ 100, empyema and infection in the pleural cavity ¿ 100, bleeding from peritoneal site ¿ 100, post-paracentesis circulatory dysfunction - 100 , persistent leakage at peritoneal insertion site ¿ 100, abdominal wall hematoma ¿ 100, infection following paracentesis ¿ 100, hypotension following paracentesis ¿ 100 , perforation of surrounding vessels or viscera ¿ 100, soft tissue injury ¿ 100.

• Brand Name: THORA-PARA VALVED (TPT)
• Type of Device: NA
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13253190
• MDR Text Key: 283814821
• Report Number: 1625685-2022-00007
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMCF SURVEY
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other