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

Lot Number C302-KIT

Device Problem Low Readings (2460)

Patient Problems Headache (1880); No Code Available (3191)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Customer called to report she had to stop the bowl due to the bowl optic sensor dropping into the low 100's; bowl optic sensor reading was in the 220's.Css asked the customer to start the procedure and advised them against pausing the procedure in this situation because it would pack the rbc's even tighter and potentially make the problem worse.Operator verbalized understanding.After the procedure was started, the bowl optic sensor again went down to the low 100's and a rbc pump alarm occurred.Css had the customer stop the bowl right away and restart the procedure again.Css again waited while the interface was established and the bowl optic sensor went to the low one hundreds once again.Css advised the operator to stop the bowl and start it back up, as she had done before.This time the bowl optic sensor was able to be maintained at 150.The donor unit was disconnected and the pt was disconnected at this point.No further issues reported.Update (b)(6) 2014: customer called back with concerns of hemolysis in the bowl, customer stated that after processing 300ml of the pt's blood the buffy coat turned pink in color.Css advised the customer to abort the treatment immediately.The pt fluid balance was zero and the pt is stable.Customer states that due to access problems they were only able to flow at 5ml/min, therefore the treatment had been going on for over two and a half hours.Customer stated this was the pt's second ecp treatment using her newly placed cvl double lumen central line.Customer stated the pt's blood pressure and heart rate have been stable throughout the treatment, but was not able to get a good reading post treatment.Customer also stated that the bowl optic sensor is clean.The pt treatment used 4,300 units of heparin in a 500ml of normal saline set at 10:1 for the a/c ratio, pt platelet count is 46,000.Update (b)(6) 2014: customer called back to report pt was hospitalized on (b)(6) 2014 after the procedure.Customer reported that when pt left the facility, pt was stable but was complaining of a headache.Pt was given tylenol.Customer stated pt returned to the hosp due to rust color urine observed in pt's diaper.The pt was hospitalized that same day.Css asked if pt was given a transfusion, customer stated no, pt was not transfused.Pt's hematocrit at time of er visit was 37.6%.Css asked if pt is stable now, customer stated yes, pt was discharged and is in stable condition.

Manufacturer Narrative

Batch record review of lot c302 was conducted.There were no non conformances related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected; however, there is currently a capa ((b)(4)) opened to investigate cellex's red blood cell pump alarms related issues.The instrument performed as expected; however, therakos has elected the report this event due to pt's hospitalization.The assessment is based on info available at the time of the investigation.No product was returned for investigation, therefore, the root cause cannot be determined based solely on the info provided by the customer.Complaints are monitored through tracking and trending; if add'l info is received the complaint will be reopened and processed accordingly.(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 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3869066
• MDR Text Key: 4455060
• Report Number: 2523595-2014-00098
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• 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: 04/09/2014

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: 01/01/2016
• Device Lot Number: C302-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 22