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

Lot Number E302-KIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used treatment.A batch record review of kit lot e302 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances 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.The assessment is based on information 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 information provided by the customer.The root cause of this issue was operator error, due to the fact that the saline and anticoagulant bags were switched.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 during a single needle mode treatment procedure.The customer stated that they had pulled some clots out of the return line at about 839 ml of whole blood processed.The customer checked to ensure that the anticoagulant bag was spiked using the green line tubing, however the customer noted that the saline and anticoagulant bags were switched.The customer agreed to abort the procedure with no return of blood/products to the patient.The patient's estimated blood loss was calculated to be approximately 280ml.The customer stated that the patient was in stable condition.This is being reported only due to the malfunction as there was no adverse event reported.The customer elected not to return the kit for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5625769
• MDR Text Key: 45141122
• Report Number: 2523595-2016-00114
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2016

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: 01/01/2018
• Device Lot Number: E302-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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