MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

Device Problem Use of Device Problem (1670)

Patient Problems Fainting (1847); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Pain (1994); Sweating (2444); Pallor (2468)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the surgery, saline, and ringer's solution that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.The instrument has been located at the customer's site since (b)(6) 2013.The customer has their own biomed who performs all of the service on this instrument.The smart card was returned for investigation.Prime was completed and blood collection was started in double needle mode with auto flow control.Thirty two minutes later an alarm #16: collect pressure alarm occurred but the customer was able to resolve the alarm and continue with the treatment.The smart card data also indicated that a saline bolus of 100 ml was administered to the patient after the alarm #16: collect pressure alarm.The photoactivation phase of the treatment was started, but the customer pressed the end treatment button before photoactivation was initiated.Several alarm #17: return pressure alarms then occurred due to pressure above the upper limit and these alarms were the last events recorded on the smart card.The review of the smart card data did not indicate that there was an issue with the treatment.The root cause for this case is use error as the patient's vein was perforated by the customer supplied 18g, steel dialysis needle.The vein perforation allowed fluids being delivered backed to the patient by the instrument to leak into the surrounding tissue causing a hematoma.Trends were reviewed for complaint categories pain, hypotension, pale, sweating, fainting, and hematoma.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 terms: pain, hypotension, pallor, sweating, fainting, and hematoma.(b)(4).

Event Description

The customer reported that an obese extracorporeal photopheresis (ecp) patient experienced pain, hypotension, paleness, sweating, fainting, and a hematoma during an ecp treatment procedure on (b)(6) 2020.The customer stated that the patient's ecp treatment procedure was run in double needle mode with automatic flow rates and customer supplied dialysis needles (steel, 18g) were used for both the collection and return.The customer reported that the patient's blood pressure (bp) before the treatment was 125/79mmhg and the patient's heart rate was 72 beats per minute (bpm).The customer stated that the patient complained of pain in his right arm from his biceps up to his shoulder/subclavic bone about thirty minutes into the procedure.The customer reported that the kit's return line was attached to the patient's right arm.The customer stated that the patient then experienced hypotension and the patient's treatment was briefly paused.The customer reported that approximately 100ml of saline was administered to the patient via the instrument's "saline bolus button" through the kit's return line.The customer stated that the patient's blood pressure was 116/79mmhg and their heart rate was 55 bpm following the saline bolus so they continued with the patient's treatment.The customer reported that at about 1500ml of whole blood processed, the patient's face became grey and he experienced cold sweats.The customer stated that the patient complained of increasing pain in his right arm and then became unconscious for approximately thirty seconds.The customer reported that they could not read the patient's blood pressure on their instruments.The customer stated that a physician was called to the ward and an ecg was performed but no abnormalities were found.The customer reported that a fluid bolus of 300ml of saline was administered to the patient via an external infusion line connected to the smartsite/needle free injection port on the kit's return line.The customer reported that the patient's systolic blood pressure was 85mmhg after the saline bolus; however, they still could not measure the patient's diastolic blood pressure.The customer stated that they could not feel any distal pulsation in the patient's right arm.The customer reported that both a hematologist and vascular surgeon arrived and 1000ml of ringer's lactate solution/hartmann's solution was quickly administered to the patient.The customer stated that the patient's systolic blood pressure increased to 95mmhg following the infusion.The customer reported that the patient was then taken to the operating room where a subcutaneous deep hematoma was found within the patient's right arm.The customer stated that after the evacuation of the patient's hematoma, the surgeon noticed that there were two perforations within the patient's vein that was used for the return.The customer reported that the patient was now in stable condition and had undergone another ecp treatment procedure on (b)(6) 2020.The customer stated that there was no sequelae or heart issues due to this incident.The customer reported that this incident would have most likely have caused a pressure alarm on a dialysis machine, but admitted that the flow rates are much lower on a cellex instrument.The customer stated that this incident was related to the use of perforative dialysis needles made of steel.The customer reported that they did not notice if the patient had bent his arm or not during his treatment.The smart card 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: 10557803
• MDR Text Key: 209845910
• Report Number: 2523595-2020-00109
• Device Sequence Number: 1
• Product Code: LNR
• 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: 09/19/2020

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR