MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEZ PHOTOPHERESIS SYSTEM

Lot Number C123/486

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Customer reported centrifuge bowl leak/break at wbpv approx 200 ml.Single needle mode procedure.Access: hickman catheter.Platelet count: 32000.Ac: heparin 1000 iu in 500ml saline, ratio 10:1.Pt was in stable condition, new treatment was performed on second machine successfully.Customer ordered service to check and clean the machine.Update (b)(4) 2014: therakos field engineer talked to the operator and operator stated: she was right next to the system when it happened.No noise change or anything like that, just a sudden noise and the alarm.She switched off the system right away.No pt issues.Service order (b)(4) was dispatched.Photos and the smart card data were sent for investigation.

Manufacturer Narrative

A review of lot c123 was performed and there were no nonconformances related to this complaint.This lot met release requirements.Trends were reviewed for complaint category, centrifuge bowl leak/break, and no trend was detected.Capa (b)(4) was initiated for further investigation of centrifuge bowl leaks/breaks.Service order (b)(4) completed: service engineer cleaned the machine after centrifuge bowl break.Leak detector and drive tube retainer clips were replaced.Calibrated bowl optics after replacement.Performed system checkout to confirm operation.No further action required.The assessment is based on info available at the time of the investigation.Eval of the photographs and smart card data is still in progress at the time of this report.A supplemental report will be filed when this eval is complete.(b)(4).

• Brand Name: THERAKOS CELLEZ PHOTOPHERESIS SYSTEM
• Type of Device: CELLEZ
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4361488
• MDR Text Key: 5261314
• Report Number: 2523595-2014-00317
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Lot Number: C123/486
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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 Age: 18 YR