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

Lot Number C128/434

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

Patient Problems Death (1802); Respiratory Distress (2045); Patient Problem/Medical Problem (2688)

Event Date 08/27/2015

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.A review of kit lot c128 was performed and there were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for complaint categories, other adverse event (hypoxemia) and death; no trends were observed.No corrective and preventive actions were initiated.According to internal medical assessment, patient had difficult respiration during exercise without chest pain.Since he'd been having more difficult respiration, he visited at (b)(6) univ.Hospital.Spo2 (at rest): 96% spo2 (during exercise): 88% no activate inflammation, but sign of wide air trapping.Because of unknown reasons for spo2 decay, he was admitted for examination.Comment by caregiver: "now, bronchiolitis obliterans or lung infarction, and so on are thought to be aftereffects of sae, but we cannot identify the cause.I think no relation between sae and the investigational device." dates of ecp treatments: (b)(6) 2014, (b)(6) 2015.Date of sae (b)(6) 2015.A full 10 days past last treatment.Hence, there is no temporal relationship to uvadex or the device/ treatment and the sae is not related/unlikely related to the sae.Update on march 9, 2015 does not change assessment.Update 5/8/2015: the system was used for treatment of disease.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contribute to a death or serious injury; and or the system did not cause or contribute to a death or serious injury nor 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 ae is related to the patient's underlying condition.There is no temporal relationship between the ae and ecp procedure.This case not is reportable as an mdr.Update: on (b)(6) 2015 - "a chest ct diagnosis and pulmonary function test indicated obliterating bronchiolitis.Compared to the time of ecp treatment start-up, the frequency of interruption to the ecp instrument has been decreased, and there is no timewise relation.There is no relation of the ae and the ecp instrument." patient had been admitted for pneumonia on (b)(6) 2015.Gastric juice testing showed no tuberculosis.Rituxan was administered on (b)(6) 2015.On (b)(6) 2015, crp 2.7mg/dl, body temperature was slightly elevated (37.4 c), cravit was started.On (b)(6) 2015, spo2 was decreased tentatively (86%-94%).Rituxan was administered.X-ray was conducted.Shadow of upper lung zone was improving; however shadow still remained to the upper area.On (b)(6) 2015, spo2 98% (o2 4l nasal).Medication was changed from cravit tablet to zosyn.On (b)(6) 2015, patient visited the hospital for follow-up (week 36).Spo2 99%, pulmonary score of cgvhd was 2.Ecp follow up term was completed.On (b)(6) 2015, hollowing out of inside was observed shadow of right upper lung zone.Amikacin sulfate was started.On (b)(6) 2015, amikacin sulfate was completed.Patient suddenly had respiratory discomfort and the symptoms disappeared without treatment.On (b)(6) 2015, 15:10 pco2 76.8torr, 17:56 pco2 76.5 torr.Patient had severe respiratory discomfort and respiration control by bipap was started.Morphine hydrochloride was administered due to persistent respiratory discomfort.Prednisolone was administered.On (b)(6) 2015, pco2 98.1torr.Respiration control by bipap was conducted; however, patient's respiration condition was getting worse.He was moved to icu and underwent intratracheal intubation.Renal dysfunction was observed and all internal remedy was discontinued.Prednisolone was started.On (b)(6) 2015, 5:00 pco2 76 torr.11:00 pco2 75.0 torr.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contribute to a death or serious injury; and or the system did not cause or contribute to a death or serious injury nor 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 ae is related to the patient's underlying condition.There is no temporal relationship between the ae and ecp procedure.This case not is reportable as an mdr.Update: on (b)(6) 2015: patient had respiratory discomfort.Spo2 was 93-95%.Right pleural effusion was observed and he underwent pleural effusion puncture.Effectiveness of pleural effusion was negative and it looks like chylous pleural effusion.On (b)(6) 2015, the liver function disorder aggravated despite discontinuing zosyn and zosyn was not possible cause.Inflammatory reaction was increased.(crp3.2mg/dl) and administration of zosyn was restarted.On (b)(6) 2015, patient had respiratory discomfort and spo2 was 85% at one point.He underwent pleural effusion puncture and symptoms were getting better after that.Pleural effusion puncture would be conducted as needed.On (b)(6) 2015, progressed liver function disorder and severe respiratory discomfort were possible liver disorder and lung disorder due to chronic gvhd.Neoral solution was started.On (b)(6) 2015, pleural effusion puncture was conducted once every other day.Pleural effusion was bloody gradually and he was diagnosed as hemothorax.Hb 6.3g/dl.On (b)(6) 2015, hb 10.6g/dl.Doctor believed hemostasis was ok.Patient had no respiratory discomfort.The doctor described there should not be any relation to the ecp treatments because some time has passed already since the ecp treatment that terminated on (b)(6) 2015.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contributed to a death or serious injury; and or the system did not cause or contributed to a death or serious injury nor 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 ae is related to the patient's underlying condition.There is no temporal relationship between the ae and ecp procedure.This case not is reportable as an mdr.Update: 8/31/2015: on (b)(6) 2015, no respiratory discomfort was observed.Cravit was discontinued.On (b)(6) 2015, crp15.57mg/dl.Started administration of finibax.On (b)(6) 2015, crp14.17mg/dl.Morphine administration was discontinued.On (b)(6) 2015, crp22.18mg/dl.Blood pressure was dropping down to 50's /30's without any cause and spo2 was 87-89%.Heart rate became 0 (flat heart rate) at 22:50 and it returns of spontaneous circulation without any intervention after that.On (b)(6) 2015, blood pressure had kept 40's and spo2 80's%.Blood pressure and spo2 had been gradually decreasing and the patient expired at 20:48 on (b)(6) 2015.The doctor described there should not be any relation to the ecp treatments as some time has passed already since the ecp treatment that terminated on (b)(6) 2015.The system was used for treatment of disease.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contributed to a death or serious injury; and or the system did not cause or contributed to a death or serious injury nor 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 ae of death is related to the patient's underlying condition.Since this is a death case, the case is reportable as an mdr.(b)(4).

Event Description

Customer reported that a patient suffered from hypoxemia on the (b)(6) 2015.Patient was reported to be hospitalized.On (b)(6) 2015, the patient had not recovered.On (b)(6) 2014, icf was taken.Cgvhd score /lung:0.On (b)(6) 2014, clinical trial started.On (b)(6) 2015, 16th week ecp treatment.Spo2:95%.Cgvhd score/lung:0.On (b)(6) 2015, patient had difficult respiration during exercise without chest pain.On (b)(6) 2015, patient visited at (b)(6) univ.Hospital.Spo2 (at rest): 96% spo2 (during exercise): 88% no active inflammation, but sign of wide air trapping.Because of unknown reasons for spo2 decay, he was admitted for examination.Comment: now, bronchiolitis obliterans or lung infarction, and so on are thought to be aftereffects of sae, but cause cannot be confirmed.Principal investigator stated that he believes there is no relation between sae and the device.Dates of ecp treatments: (b)(6) 2014, (b)(6) 2015.No evidence of pulmonary embolism in the submitted reports.Patient does require continuous use of oxygen via nasal cannula at this time.Precise diagnosis: only hypoxemia at this time.Clinical services specialist reported on (b)(6) 2015: according to the reporter, there is no relationship between the event and ecp treatment.According to therakos trainer at (b)(6) univ hospital, the patient is now on portable oxygen, and there were no other reported negative effects at this time.Update mar 9, 2015: additional information was received from the css: md changed "hypoxaemia" to "bronchiolitis obliterans" by ct and lung function test.There is no negative event after the ecp treatments on (b)(6).No evidence of pulmonary embolism.Update 28 april 2015: the patient's condition was reported as improved on (b)(6) 2015.According to the reporter, there is no relation of the ae and the ecp instrument.Update 19 june 2015: patient was admitted to the hospital for pulmonary pneumonia on (b)(6) 2015.Rituxan was administered on (b)(6) 2015.Crp 2.7 mg/dl, body temperature was slightly elevated (37.4c), cravit was started.Spo2 was decreased tentatively (86%-94%).Rituxan was administered.X-ray was conducted.Shadow of upper lung zone was improving.On (b)(6) 2015: spo2 98% (o2 4l nasal).Medication was changed from cravit to zosyn.On (b)(6) 2015: patient visited the hospital for follow-up (week 36).Spo2 99%, pulmonary score of cgvhd was 2.Ecp follow-up term was completed.On (b)(6) 2015: hollowing out of inside was observed shadow of upper right lung zone.Amikacin sulfate was started.On (b)(6) 2015: amikacin sulfate was completed.Patient suddenly had respiratory discomfort but symptoms disappeared without treatment.On (b)(6) 2015: the patient had severe respiratory discomfort and respiration control by bipap was started.Morphine hydrochloride was administered due to persistence of respiratory discomfort.Prednisolone was administered.Respiration control by bipap was conducted; however patient's respiration condition was getting worse.Patient was moved to icu and underwent tracheal intubation.Creatinine was administered.Renal dysfunction was observed.Prednisolone was stared.On (b)(6) 2015: 5:00 pco2 76torr.11:00 pco2 75.0torr.Update 18 aug 2015: on (b)(6) 2015: liver function disorder was worsened gradually.Pneumonia is stable and zosyn was discontinued due to possible cause of liver function disorder.On (b)(6) 2015: patient had respiratory discomfort.Spo2 was 93-95%.Right pleural effusion was observed.He underwent pleural effusion puncture.Infectiveness of pleural effusion was negative and it looks like chylous pleural effusion.On (b)(6) 2015: the liver function disorder aggravated in spite of discontinuing zosyn.Inflammatory reaction was increased and administration of zosyn was restarted.On (b)(6) 2015: patient had respiratory discomfort and spo2 was 85% at one point.He underwent pleural effusion puncture and symptoms were improving after that.On (b)(6) 2015: progressed liver function disorder and severe respiratory discomfort.Possible liver disorder and lung disorder due to chronic gvhd.Neoral solution was started.On (b)(6) 2015: pleural effusion puncture was conducted once every other day.Pleural effusion was bloody gradually and he was diagnosed as hemothorax.Hb6.3g/dl.On (b)(6) 2015: hb 10.6g/dl.Doctor believed hemostasis was ok.Patient has no increased pleural effusion and no respiratory discomfort.On (b)(6) 2015: crp 9.20mg/dl.Teicoplanin was started.On (b)(6) 2015: crp 12.13mg/dl.Zosyn was discontinued and cravit was started.On (b)(6) 2015: crp 11.93mg/dl.On (b)(6) 2015: no respiratory discomfort was observed.Cravit was discontinued.The following was reported on (b)(4): on (b)(6) 2015: crp15.57mg/dl.Started administration of finibax.On (b)(6) 2015: crp14.17mg/dl.Morphine administration was discontinued.On (b)(6) 2015: crp22.18mg/dl.Blood pressure was dropping down to 50's /30's without any cause and spo2 was 87-89%.Once his heart rate became 0 (flat heart rate) at 22:50 and it returns of spontaneous circulation without any intervention after that.On (b)(6) 2015: blood pressure had kept 40's and spo2 80's%.Blood pressure and spo2 had been gradually decreasing and patient expired at 20:48 on (b)(6) 2015.

• 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: 5078298
• MDR Text Key: 25865237
• Report Number: 2523595-2015-00238
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2015

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: Physician
• Device Expiration Date: 08/01/2016
• Device Lot Number: C128/434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2015
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Death
• Patient Age: 42 YR
• Patient Weight: 59