MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); No Code Available (3191)

Event Date 08/29/2019

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 extra fluids and blood transfusion that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No service was requested by the customer for this adverse event.A device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2017.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2018.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The root cause for this event is most likely use error as the customer has acknowledged that they may have forgotten to open the clamp to the bag of packed red blood cells (donor unit) and close the clamp to the patient during the buffy coat collection stage of the ecp blood prime treatment procedure.In an ecp blood prime treatment procedure, the donor unit of packed red blood cells (prbc ) is used at two different points during the procedure: to fill up the machine with blood prior to connecting the patient, in order to keep the patient isovolemic from the start and to push the buffy coat out of the centrifuge bowl once the whole blood processed target is reached.This is otherwise generally known as the moment during the treatment were the highest amount of red cells are outside of the body.In order to ensure step 2 the operators must turn a 3-way stopcock (and open the donor unit clamp) to stop drawing blood from the patient and instead draw from the prbc donor unit.At this same stage, the blood prime feature of the instrument sets the return rate to 0 ml/min (since no blood is supposed to be drawn from the patient).There should be no fluid going to or from the patient at this point.If the operator forgets to turn the stopcock, they will continue to draw from the patient, without any blood returning to the patient.The theory that the customer forgot to open the clamp to the donor unit and close the clamp to the patient during the buffy coat collection stage of the ecp blood prime treatment.Was further supported by the fact that the customer initially reported that the buffy coat was not being pushed out of the centrifuge bowl.If the customer was using the door unit of prbc with a 55% hematocrit, this should not have been a problem.On the other hand, if the customer was using the patient's blood at 26% hematocrit, pushing out the buffy coat would have been more of a challenge.Therakos recommends a hematocrit of 27% or higher for patients undergoing cellex ecp treatment procedures.Trends were reviewed for complaint categories, malaise, cough, mucus, and hypotension.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.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced malaise, cough, mucus, and hypotension during a treatment procedure.The customer reported that the patient was "not fully fit" prior to his ecp treatment procedure.The customer stated that the patient was a little unwell that day and it was unrelated to his ecp treatment procedures.The customer reported that the patient was coughing a lot and he had a lot of mucus.The customer stated that the patient was currently on an antibiotics treatment for these symptoms.The customer reported that the patient's labs were performed on the same day as the patient's treatment; however, no one had checked the patient's lab results or made a decision on whether or not he should have had a blood transfusion prior to his ecp treatment procedure.The customer stated that the patient's pre ecp hematocrit (hct) reading was quite low, 26%, his hemoglobin (hgb) level was 8.4 g/dl, and his blood pressure was 99/69.The customer reported that the patient underwent an ecp blood prime treatment procedure, which was usual for this patient.The customer stated that the patient's ecp blood prime treatment procedure started at 9:10 and went well until the buffy coat collection phase of the treatment.The customer reported that they started to stress when the treatment went to buffy coat and wondered when they should hit pause the customer stated that they then noticed that the buffy coat layer was not being pushed out of the centrifuge bowl.The customer reported that the patient also started to feel unwell at this time.The customer stated that the patient was having a coughing attack and then he developed a "mucus plug which made him lose his breath".The customer reported that they then aborted the patient's ecp blood prime treatment procedure with no blood returned to the patient at 10:30.The customer stated that the patient's blood pressure was 96/64 and their heart rate was 133 when their ecp blood prime treatment procedure was aborted.The customer stated that half an hour (11:00) later, the patient's blood pressure had dropped to 82/54 so they transfused the patient with extra fluids (400 ml nacl) and one unit of blood.The customer reported that the patient was improving and his coughing attack was over.The customer stated that new blood labs were performed fifteen minutes after the start of the patient's blood transfusion and the patient's hgb was at 8.9 g/dl.The customer reported they may have forgotten to open the clamp to the donor unit and close the clamp to the patient during the buffy coat collection stage of the ecp blood prime treatment.At this stage of the ecp blood prime treatment procedure, the blood prime feature of the instrument sets the return rate to 0 ml/min (since no blood is supposed to be drawn from the patient).If the operator forgets to switch the clamps, the instrument will continue to draw from the patient, without any blood returning to the patient.The customer stated that to her this is most likely what happened in this instance as this is when the patient started to become unwell.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: 9101840
• MDR Text Key: 163135258
• Report Number: 2523595-2019-00117
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170208
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2019
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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: 6 YR
• Patient Weight: 25