MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX SYSTEM

Lot Number C129

Device Problem Insufficient Information (3190)

Patient Problem Bronchopneumonia (2437)

Event Date 01/09/2015

Event Type  Injury  

Event Description

The clinical coordinator reported to a monitor that: patient visited a hospital in (b)(6), with cough on (b)(6) 2015.The patient got a chest x-ray test and was diagnosed with bronchial pneumonia and was required hospitalization.The pneumonia was getting better, but the patient remained in the hospital.Post the admission to the hospital, the patient was given the following medications: maxipime for injection 2g/day, codeine phosphate hydrate 3g/day, ambroxol hydrochloride 3 tablets/day.The product was not returned for investigation.

Manufacturer Narrative

A bath record review of lot c129 was conducted.There were no nonconformances.The lot met all release requirements.Trends were reviewed for complaint category, cough, and no trends were detected.Based on the assessment, the (b)(6) male with cgvhd developed cough two days after the treatment.Chest xray was performed and bronchial pneumonia was diagnosed.Patient was hospitalized and given antibiotics.Patient's pneumonia is getting better.The health care professional does not think there is relationship between the cough and ecp.This case is serious and unrelated to ecp.This case is reportable due to the medical intervention.The assessment is based on information available at the time of the investigation.No product was returned for analysis; therefore, it could not be determine if this specific product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further action will be taken through the capa/ continuous improvement process.(b)(4).

• Brand Name: THERAKOS CELLEX SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NJ 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4493701
• MDR Text Key: 5328124
• Report Number: 2523595-2015-00033
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2015

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: Health Professional
• Device Expiration Date: 08/01/2016
• Device Lot Number: C129
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 67