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

Lot Number E324-KIT

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); Hemolysis (1886); Patient Problem/Medical Problem (2688)

Event Date 08/11/2016

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e324 was conducted.There were no nonconformances associated with this lot.The 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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #17: return pressure, alarm #16: collect pressure, alarm #1: air detected, low hemoglobin, and hemolysis.No trends were detected for these complaint categories.From a device perspective, this case is reportable as a mdr since the physician was not able to rule out ecp as a possible cause for the patient's hemolysis.This case is also reportable as a mdr due to the medical intervention of the blood transfusion.The smart card was returned for analysis.A review of the smart card data confirmed the occurrence of the alarm #17: return pressure alarms.However, based on the smart card data, there was no evidence of the alarm #16: collect pressure alarms occurring during the procedure.Therefore the customer's statement that "many alarm #16: collect pressure alarms occurred during the collect phase of the procedure" could not be confirmed.The return pressure was above the upper limit set on the instrument when all of the alarm #17: return pressure alarms occurred.In addition to the alarm #17: return pressure alarms, several alarm #1: air detected alarms for air in the return line also occurred during the reinfusion phase of the procedure.Based on the available information, it could not be determined if there was an issue with the kit that could have caused or contributed to either of the alarm #17: return pressure alarms or alarm #1: air detected alarms.Based on the analysis, no remedial actions will be conducted.Adverse event terms: hemolysis and patient problem/medical problem (low hemoglobin).(b)(4).Device not returned to manufacturer.

Event Description

The customer reported that a patient's hemoglobin (hgb) dropped from 10 at the beginning of the (b)(6) 2016 procedure to 5.1 at the end of the procedure.The customer stated that hemolysis had also occurred and he thinks that it could be related to the turbulent blood flow of the procedure.The customer reported that the hemolysis was not seen during the procedure, but was later detected in lab results.The customer stated that the lab results also indicated an increase in the patient's lactate dehydrogenase (ldh) and bilirubin levels as well.In addition, the customer reported that the results of a urinalysis also indicated hemolysis.The customer stated that many alarm #16: collect pressure alarms occurred during the collection phase and there were also many alarm #17: return pressure alarms during the reinfusion phase.The customer reported that the patient was clinically stable post procedure, but was transfused with red cells due to the lab results.On (b)(6) 2016, the patient's treating physician stated that the patient's hemoglobin decrease could possibly be considered related to the patient's extracorporeal photopheresis (ecp) procedure.The physician also reported that the patient's hemolysis lab result, blood ldh increase, and blood bilirubin increase could also be possibly considered related to the patient's ecp procedure.The physician stated that a blood prime was used for this procedure.The physician reported that the blood samples used for all of the patient's lab tests were collected approximately twenty minutes into reinfusion.The physician stated that the blood samples were not drawn from either the ecp instrument's return line or treatment bag, but were instead drawn from a separate picc line that the patient had in place.The smart card was returned for investigation.

Manufacturer Narrative

Based on the additional information trends were reviewed for complaint categories, clot observed and death.No trends were detected for these complaint categories.Adverse event terms: death.(b)(4).

Event Description

Additional information was obtained from the journal article, acute mechanical hemolysis as a complication of extracorporeal photopheresis in low-weight child.Multiple high pressure alarms were encountered during collection as a result of blood clots in the collect line, which were resolved after flushing the line with normal saline.Multiple high pressure alarms were also encountered during reinfusion as a result of blood clots in the return line, which were resolved by flushing the return line with normal saline.During the procedure, no temperature alarms were encountered and blood clots were only observed in the collect and return lines, with no blood clots observed in the centrifuge bowl, treatment bag, or other tubing.The patient passed away following a septic event; the patient received 10 ecp treatments in total.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5948293
• MDR Text Key: 54630894
• Report Number: 2523595-2016-00196
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Lot Number: E324-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 21 MO
• Patient Weight: 11