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

Lot Number C314-KIT

Device Problems Device Alarm System (1012); Leak/Splash (1354); Vibration (1674)

Patient Problem Blood Loss (2597)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Customer called and reported that at about 25 minutes into the procedure, the instrument started vibrating and the operator looked into the centrifuge to see a sever blood leak.Operator reported that there was no alarm, so he powered off the instrument to stop the centrifuge bowl.Operator looked into the centrifuge chamber to see that the bowl had come out of the centrifuge bowl holder.Customer had not opened the centrifuge chamber.Css advised the customer to have the instrument serviced as it was likely that the leak detector was damaged.The patient was stable and the customer would like to set up a new kit on a new instrument to treat the patient.Css advised the customer to review the patient's safe ecv volume, refer to tech bulletin (b)(4) to determine blood loss and make sure that the patient will not exceed the safe ecv with the blood lost in the first procedure.Service order (b)(4) dispatched.Customer returned product for investigation and provided pictures for evaluation.

Manufacturer Narrative

Batch record review of lot c314 was conducted.There were no nonconformities related to this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected; however, as part of therakos, (b)(4) sigma program for continuous improvements and to reduce the occurrence for these type of events as much as possible, capas (b)(4) are already opened to investigate centrifuge bowl leaks/breaks and drive tube leaks/breaks.Service order (b)(4) completed: service engineer performed system check.Everything checked out; in specifications.Adjusted a pump.The assessment is based on information available at the time of the investigation.The product returned for investigation and the photo evaluation are still in progress at the time of this report; therefore, final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOTPHERESIS 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: 3962569
• MDR Text Key: 4611082
• Report Number: 2523595-2014-00176
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/04/2014

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: 03/01/2016
• Device Lot Number: C314-KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 54 YR
• Patient Weight: 98