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

Lot Number C123-KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 09/17/2014

Event Type  Injury  

Event Description

Customer reported that a patient had fever, 38.2 degrees c, and chills after treatment and felt very cold.Procedure was normal, there were no alarms.Photoactivation time was long, 99 minutes, due to too many rbc's in the treatment bag.Buffy coat 249 ml, 4.2 ml uvadex.The patient was stable and there were no symptoms during treatment.No additional investigations were planned.Patient left the ecp department to the ward.Clinical services specialist called back the following day: patient received paracetamol 1g, at 14:30, at 19:00 and also during the night at 2:30.It was reported on (b)(6) that the patient received a planned blood transfusion the day before ecp (in another hospital) because of very low hb and hct values.It was reported that this patient receives prbc's each time her b and hct are too low to safely perform ecp.The day after ecp, antibiotic therapy was started due to increased crp values.Nurse could not provide more details.On (b)(6) the physician confirmed the cause of the increased crp was a bladder infection and there was no relationship to ecp.The patient was admitted in the hospital four days longer than initially planned due to this infection longer than initially planned due to this infection - tazobac (penicillin-antibiotkum) was given 3x/day for five days.Patient was fully recovered when she left the hospital.

Manufacturer Narrative

Batch record review of lot c123 was conducted.There were no nonconformances related to this complaint associated with this lot.The lot met release requirements.Trends have been reviewed for complaint categories, chills and fever, and no trends were detected for either complaint category.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could not be determined if this specific product met specifications.This case is being reported due to the patient's prolonged hospitalization with bladder infection.

• Brand Name: THERAKOS CELLEX PHTOPHERESIS 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; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4171986
• MDR Text Key: 16849416
• Report Number: 2523595-2014-00263
• 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: 09/17/2014

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: 05/01/2016
• Device Lot Number: C123-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 74 YR
• Patient Weight: 63