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

Lot Number C322-KIT

Device Problems Break (1069); Leak/Splash (1354); Component Missing (2306); Device Displays Incorrect Message (2591)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

Customer reported: the kit had completed priming normally, then the bowl holder shortly after a single needle mode treatment started, at about 205 ml whole blood processed, during the initial purging air phase.An alarm occurred but the specific alarm could not be recalled.Customer had re-installed the bowl into the bowl holder and restarted the treatment.The bowl then came out of the bowl holder again, and this time the drive tube was severed close to the drive tube clamp assembly and the centrifuge leak sensor strip was damaged.The treatment was aborted and no blood was returned to the patient.When the instrument was powered on later, a system error 130 occurred.The black locking tab on the bowl holder appears to be in good operating condition.The sensorized drive tube clamp assembly might have been damaged.One of the plastic tabs at the base of the bowl is now intact, one is missing, and one is partially missing.Patient is stable and has started a new treatment on a different instrument.Service (b)(4) was dispatched.Customer will return product for evaluation.

Manufacturer Narrative

A review of lot c322 was conducted.There were no nonconformances associated with this type of failure for this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for centrifuge bowl leak no for drive tube leaks; capa's (b)(4) have already been initiated to investigate centrifuge bowl leaks and drive tube leaks.Service order (b)(4) completed: service engineer replaced leak detector strip and performed checkout procedure according to service manual.No further action required.The assessment is based on information available at the time of the investigation.The product return evaluation is still in progress at the time of this report; therefore, final investigation findings are still pending.

• 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 NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4174627
• MDR Text Key: 22002154
• Report Number: 2523595-2014-00210
• 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: 07/16/2014

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: C322-KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 26 YR
• Patient Weight: 78