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

Lot Number D321 - KIT

Device Problems Excess Flow or Over-Infusion (1311); Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Overdose (1988)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d321 was performed.There were no non-conformances related to the complaint.This lot met release requirements.A review of uvadex lot ad1437 was performed and there were no non-conformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint categories, protocol: assembly or operation, clot observed and other adverse event (blood in stool post-ecp).A downward trend was identified for protocol: assembly or operation.No trends were identified for clot observed or other adverse event (blood in stool post-ecp).No corrective and preventive actions were initiated for complaint categories, protocol: assembly or operation, clot observed or other adverse event.Per internal medical assessment, (b)(6) y/o female patient with gvhd, customer stated the patient had bloody stool prior to starting any photopheresis treatments.Patient hct before treatment was 301.4 and after treatment was 29.0.Hgb before last treatment was 10.6 and 10.14 after last treatment.Bp before treatment was 120/79 and 130/64 after treatment.Patient is also on continuous dialysis and has liver gvhd.Patient had some clotting in this treatment due to user error of setting the ac ratio of 10:1 to 50: 1 by mistake.There was no known medical intervention.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is non serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did cause or contribute to a death or serious injury; and the system did cause or contribute to a death or serious injury or malfunction in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.There is no device malfunction.The adverse event is related to the patient's underlying condition.The ae started before any ecp procedure was started.This case is reportable as an mdr due the clot in the return line.The assessment is based on information available at the time of the investigation.No product was returned by the customer for 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).Not returned.

Event Description

Operators were doing a blood prime procedure and inadvertently pushed stop instead of pause.They called to get assistance in getting the treatment back on course.Clinical services educator supported them in diverting fluid in the return bag, re-purging bowl and starting buffy coat.Operator noted a clot at the end of the return line when disconnecting from patient to waste bag.Removed and continued.Operators called a second time following photoactivate because they could not find the end tx button.At this time, the operators noted that the bowl had not emptied completely.They also noted that the volume in the return bag was lower than expected.Cse advised that this indicated the patient would has received more of the donor prbcs than usual and care should be taken to decide if reinfusion of the buffy coat is appropriate.Operators understood, and proceeded with caution and using a slow flow rate.They also did not do any rinseback to avoid fluid overload.Supervisor called (b)(6) 2015 to report blood in stool post ecp treatment and to ask if this is treatment related.The customer did not return the kit for investigation.Customer called back on (b)(6) 2015 to give further information.Customer stated the patient had bloody stool prior to starting any photopheresis treatments.Customer also stated that additional training would be conducted due to the chosen ac ratio of 50:1 during the entire treatment.Patient received 3 ecp treatment prior to this through continuous dialysis circuit.This treatment was without dialysis, however, the ac ratio selected was the same as the previous treatments.(b)(6) - customer service specialist contacted the customer to obtain current condition of patient.Customer reported patient is currently stable and has continued receiving photopheresis therapy 3 times/week with no issues.Customer reported patient is tolerating therapy well.

Manufacturer Narrative

The adverse event (bloody stool) is not reportable as it is related to the patient's underlying condition.Per an internal medical assessment, the customer stated the patient ((b)(6) female patient with liver gvhd) had bloody stool prior to starting photopheresis treatments.Patient hct before treatment was 30.4 and after treatment was 29.0.Hgb before last treatment was 10.6 and after last treatment was 10.1.Blood pressure before last treatment was 120/79 and was 130/64 after treatment.The patient is also on continuous dialysis.Some clotting occurred in this treatment, most likely due to user error in setting the ac ratio at 10:1 instead of 50:1 as the operator intended.There was no medical intervention.From a drug perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is non-serious, unrelated, and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective, this event or the treatment did not cause or contribute to a death or serious injury.Clotting occurred in the return line and was likely due to user error.However, a malfunction could not be ruled out.Therefore, this case is reportable as an mdr.(b)(4).

• 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: 4932503
• MDR Text Key: 23836643
• Report Number: 2523595-2015-00205
• 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: Other
• Report Date: 07/06/2015

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: 04/01/2017
• Device Lot Number: D321 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 7 YR
• Patient Weight: 20