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

Lot Number C156-KIT

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A discrepancy in the kit lot number was noticed when the smart card was returned.The kit lot number on the returned smart card was c156, which matched the kit lot number that was initially given to therakos.However, the accompanying paperwork with the smart card stated that d103 was the kit lot number.Since both kit lots were shipped to the customer, we will include both lot numbers in this report.A batch record review of kit lot c156 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A batch record review of kit lot d103 (manufacture date: 01/01/2015 and expiration date: 01/01/2017) was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or non-coformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #17: return pressure and clot observed.No trends were detected for these complaint categories.However, a corrective and preventive action was initiated for complaint category, alarm #17: return pressure, and is now closed.No corrective and preventive action was initiated for complaint category, clot observed.Product return analysis: the smart card was received for analysis.The data confirmed the occurrence of multiple return pressure and return air detected alarms as well as a system error #8 alarm.The occurrence of the return pressure and return air detected alarms is consistent with an occlusion in the return line, such as the clot observed by the operator.The system error #8 alarm occurs when the air pressure, to the occluders, is greater than 50 psi.The data showed that the air pressure was 77 psi when the system error #8 occurred.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report an alarm #17: return pressure alarm that could not be reset.The customer reported that the alarm could not be cleared.The alarm began after the centrifuge bowl had emptied, and photoactivation had started.The return bag contents were being returned to the patient.The customer switched the patient from double to single mode early on in the procedure due to access performance.The customer reported that the anticoagulant ratio was set at 10:1, with a heparin concentration of 15,000/500ml normal saline.The customer checked the return line for occlusions, pinch points, and closed clamps.The customer verified that the patient's return access was acceptable for the flow rate.The customer observed clotting in the return bag, return line, and centrifuge bowl.It was recommended to the customer to stop the procedure, clamp both the return and collect lines, disconnect the patient from the kit and instrument, and abort the treatment.The customer agreed and aborted the treatment.The customer confirmed that no blood products would be returned to the patient.After consulting with the physician, the customer determined that no medical intervention would be necessary.On (b)(6) 2015, the customer reported that the patient's next procedure was completed successfully, and the patient tolerated the procedure without any difficulty.No service order was generated.The smart card was returned for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4943553
• MDR Text Key: 23916942
• Report Number: 2523595-2015-00206
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 06/29/2015

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: Nurse
• Device Expiration Date: 07/01/2016
• Device Lot Number: C156-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 43 YR
• Patient Weight: 64