MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX SYSTEM

Lot Number C306/687-KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Customer called to report a blood leak.Customer stated after processing 200ml, she heard a loud noise, and blood splattered inside the centrifuge.Blood leak alarm occurred.Customer stated the tubing in the middle of the drive tube has a crack in it.The drive tube bearings are still loaded.Customer did not want to send the kit back due to the mess.Customer states the pt is stable.Pt pre-blood work was unavailable.Service order (b)(4) was dispatched to service instrument.Customer returned product for investigation.

Manufacturer Narrative

Batch record review of lot c306 was conducted.There were no non conformances related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected; however there are currently two capa's ((b)(4)) opened to investigate cellex's blood leaks in the centrifuge and drive tube leak/breaks related failures.The assessment is based on info available at the time of the investigation.The kit was received for analysis; however, no root cause has yet been determined as the investigation is still ongoing.(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 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3949008
• MDR Text Key: 15359345
• Report Number: 2523595-2014-00112
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2014

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: 02/01/2016
• Device Lot Number: C306/687-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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: 67 YR
• Patient Weight: 81