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

Lot Number C105/434 - KIT

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Account manager called to translate a complaint from the customer.Customer, css, and account manager were all conferenced into the call.Customer reported that the centrifuge bowl came off of the platform during buffy coat collection and caused a blood leak.Css asked if there were any alarms prior to the break.Customer stated the treatment was going well, only had one collect pressure alarm, and they lowered the collect rate to resolve it.Customer disposed of the kit and wiped the instrument.Customer stated the leak detector appears to be intact.Css advised the customer to wipe the leak detector with white vinegar per the user manual, and allow it to dry.Customer stated she will continue to use the instrument if it powers up without problems after cleaning.Patient was stable but rec'd a 250ml saline bolus for fluid replacement after the aborted treatment.No other interventions were done at the time of this call.Service order (b)(4) was dispatched.Customer did not return product for investigation.

Manufacturer Narrative

A review of lot c105 was conducted.There were no non-conformances associated with 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/breaks; capa (b)(4) is already opened to investigate centrifuge bowl leak/breaks.Service order (b)(4) completed: service engineer cleaned with javex 1:10; replaced collect pressure sensor; performed a complete system checkout, result ok; report set to customer.No further action required.The assessment is based on info available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the info provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS 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, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4030876
• MDR Text Key: 4846318
• Report Number: 2523595-2014-00197
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/07/2014

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: C105/434 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/30/2014
• 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: 55 YR
• Patient Weight: 79