MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Anemia (1706); Dyspnea (1816); Fatigue (1849); Pallor (2468)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the blood transfusion and iron supplements that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.A device service history was not conducted for this case as this issue was not related to any specific instrument.Anemia is a known and labeled event that can occur if the patient's treatment frequency exceeds the labeling recommendation.In chapter 2-2 of the operator's manual under the adverse reactions section, it states " treatment frequency exceeding labeling recommendations may result in anemia." in chapter 2-8 of the operator's manual the normal treatment frequency is listed as "the patient should receive treatment on two successive days each month for six months.Patients who fail to show an "adequate response" to treatment after eight treatments may have their treatment schedules increased to two successive days every two weeks for the next three months.If no response, or less than an "adequate response" is achieved after 20 treatments, use clinical judgement to decide if ecp should be continued." the customer stated that the patient's anemia started after the patient underwent twice a week ecp treatment procedures for eleven weeks.Trends were reviewed for complaint categories, anemia, pallor, fatigue, and shortness of breath.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event term: anemia, pallor, fatigue, and dyspnea.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced anemia following a treatment procedure.The customer called to ask how many red blood cells were left in the kit at the end of an ecp treatment procedure.The customer was directed to technical bulletin number 8, which states 115ml of residual volume is left in the kit at the end of every ecp treatment procedure.The exact amount of red blood cells that are left in the kit at the end of an ecp treatment procedure is unknown.The customer asked if there was any way to reduce this residual volume within the kit.The customer also asked if there were any reports of patients developing iron deficiency anemia while on ecp treatment and if so how to prevent this anemia from occurring.The customer reported that he had a patient who may have developed iron deficiency anemia due to her ecp treatment procedures.The customer stated that a downward trend was noted in the patient's hemoglobin levels after a month of the patient receiving ecp treatments procedures twice a week on a weekly basis.The customer reported that all of the patient's ecp treatment procedures had been successfully completed with both blood and treated cells returned to the patient at the end of each treatment.The customer stated that the patient started her ecp treatment procedure on (b)(6) 2018.The customer reported that the patient's ecp treatment schedule was twice a week for 8 weeks, followed by twice a week every other week for 8 weeks, and finally twice a week, once a month.The customer stated that the patient had some deviation from her ecp treatment schedule during phase two of her treatment (twice a week, every other week, for 8 weeks), as the patient continued to come weekly for her treatments.The customer reported that the patient's iron levels were drawn on (b)(6) 2018, which showed iron deficiency anemia.The customer stated that the patient received two units of packed red blood cells (prbc) in the infusion center after her ecp treatment procedure on (b)(6) 2018 due to the patient's anemia causing signs and symptoms such as pallor, fatigue, and shortness of breath.The customer reported that the patient's hemoglobin level increased from 6.9 g/dl pre-transfusion to 8.9 g/dl post-transfusion.The customer stated that the patient was also started on supplemental iron [slow fe (as elemental iron) 45 mg oral tablet].The customer reported that the patient's ecp treatment procedures were stopped on (b)(6) 2018 during the sixth week of the patient's phase two-treatment schedule, since the patient's skin graft versus host disease was still progressing despite the patient's ecp treatment procedures.The customer stated that the patient's anemia is now resolved and the patient is off the oral iron supplements.The customer reported that the patient's most recent hemoglobin reading was 11.6 g/dl on (b)(6) 2019, which was about eleven months after the patient's last ecp treatment procedure.The customer stated that the patient's ecp treatment procedures could have caused or contributed to the patient's anemia since the patient's anemia coincided with the initiation of the patient's ecp treatment.The customer reported that many of their ecp patients experience a drop in their hemoglobin level when starting their ecp treatment procedure, but most patients do not necessitate treatment.The customer stated that given that this patient was chronically ill; there is a risk of anemia however, this would not necessarily explain the onset of this patient's iron deficiency anemia.The customer reported that given the temporal association between the patient's anemia and their ecp treatment procedure in addition to the fact that this anemia has occurred in other ecp patients; this would argue in favor of the patient's ecp treatment procedure as being the primary etiology of the patient's iron deficiency anemia.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 8900042
• MDR Text Key: 154555356
• Report Number: 2523595-2019-00103
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 115