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

Lot Number C307 - KIT

Device Problems Material Fragmentation (1261); Leak/Splash (1354)

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Customer reported a blood leak occurred in the centrifuge near the end of the initial purging air phase, at approximately 200 ml whole blood processed.Customer stated the single needle mode treatment was aborted and the blood in the kit was not returned to the patient.Customer stated the patient was being given saline per physician's order after the treatment was aborted.Customer stated the bowl had broken into pieces and provided two photos of the broken bowl in the centrifuge.Customer stated the bowl had been locked securely into the bowl holder and had been checked carefully.Service was dispatched to replace the leak sensor strip and to clean and check out the instrument.The kit was inadvertently discarded and is not available for return.

Manufacturer Narrative

A review of lot c307 was performed and there was one non-conformance associated with this lot.Inc16137 was initiated for drive tube delamination.Manufacturing procedure bounds the failure by additional testing of procedural kits where the failure has occurred.The lot met release requirements.At the time of the investigation, no trends were detected for complaint categories, drive tube leak/break or centrifuge leak/break.Capa (b)(4) has been initiated for drive tube leaks/breaks.Capa (b)(4) has been initiated for centrifuge bowl failures.Service order (b)(4) completed: field engineer cleaned the instrument.Centrifuge bowl was found broken.Replaced centrifuge leak detector strip and fixed centrifuge bearing clip.Ran system checkout.The assessment is based on information available at th time of the investigation.Analysis of the photos sent by the customer is still in progress at the time of this report; therefore, final investigation findings are still pending.(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 NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4202629
• MDR Text Key: 5146419
• Report Number: 2523595-2014-00246
• 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: 08/25/2014

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: C307 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 90