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

Lot Number C139

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem Fainting (1847)

Event Date 12/03/2014

Event Type  Injury  

Event Description

Customer reported alarm #54: anticoagulant line air detected at whole blood processed volume (wbpv) 533ml.Treatment was planned with wbpv target of 1300ml.Treatment was performed in single needle mode with blood prime.Alarm #52: collect line air detected occurred after alarm #54.Customer observed air bubbles in the ac and collect line.Customer decided to end the treatment at wbpv 740ml because of returning alarm #54 and alarm #52.Patient platelet count 80000.Anticoagulant: heparin 10000 iu in 500ml saline, ratio 10:1 access: hickman catheter.Blood prime with rbc after treatment ended, patient collapsed and stopped breathing.Patient was stable after medical intervention.Patient was provided with one rbc transfusion.Bp after medical intervention 113/54 mmhg customer will send smart card for investigation.No service order was generated.

Manufacturer Narrative

Batch record review of lot c139 was performed.There were no nonconformances associated with this lot.This lot met release requirements.A review of lot c139 shows no trends.Trends were reviewed for complaint categories, alarm #54: anticoagulent line air detected, alarm #52: collect line air detected, and fainting.No trends were detected.There were no capas initiated.The patient was stable after medical intervention and transfusion.This case is serious and related to therapy.This assessment is based on information available at the time of this report.The smart card was returned for evaluation.A supplemental report will be filed when this analysis is complete.Kit unique identifier (udi) #: (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 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, ste 140; bridgewater, NJ 08807
• MDR Report Key: 4360452
• MDR Text Key: 5113400
• Report Number: 2523595-2014-00331
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Lot Number: C139
• Other Device ID Number: 10705030100009
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10