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 Pulmonary Embolism (1498); Low Oxygen Saturation (2477)

Event Date 01/30/2019

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 saline nebulizer, furosemide 20mg iv, oxygen therapy, and clexane 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.An instrument serial number was not provided.The distributor has their own biomed who performs all of the service for their instruments trends were reviewed for complaint categories,pulmonary embolism and oxygen desaturation.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: pulmonary embolism and oxygen saturation, low.Mc (b)(4), (b)(6) 04/12/2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a pulmonary embolism and oxygen desaturation following a treatment procedure.The customer stated that the patient underwent an ecp treatment procedure on (b)(6) 2019 via a permcath using acda as the anticoagulant at a 10:1 ratio.The customer reported that the patient had been transferred to their unit from another hospital where the patient had been admitted for pneumonia.The customer stated that the patient arrived at their site on a continuous positive airway pressure machine.The customer reported that upon arrival to their unit the patient's oxygen saturation was at 90 - 92% ra (target 88 - 92% per transplant team).The customer stated that the patient was also mildly tachycardic at 110 beats per minute.The customer reported that the patient demonstrated increased shortness of breath and use of accessory muscles.The customer stated that the patient was reviewed by their medical officer prior to their ecp treatment procedure and the patient was approved to proceed.The customer reported that alteplase was administered in the patient's permcath due to the catheter not yielding any blood.The customer stated that the patient's ecp treatment procedure was performed once the patient's permcath was able to yield blood.The customer reported that upon successful completion of the patient's ecp treatment procedure it was observed that the patient's oxygen saturation was now at 70% while on 3 liters of oxygen via nasal prongs.The customer stated that a medical emergency was called due to the patient's oxygen desaturation.The customer reported that at the time of the patient's oxygen desaturation the patient received a saline nebulizer, furosemide 20mg iv, and oxygen therapy.The customer stated that an electrocardiogram was performed as well as a complete blood exam.The customer reported that a ct pulmonary angiography was also performed which confirmed a pulmonary embolism.The customer stated that the patient was then transferred to another hospital and admitted.The customer reported that they were informed that the patient was given clexane for their pulmonary embolism but were unaware of any further medical interventions as the patient was admitted to a different hospital.The customer stated that patient had been discharged but they did not know the patient's exact discharge date.The customer reported that they believed that the patient may have been admitted for approximately 48 hours.The customer stated that the patient was currently in end of life care.The customer reported that the patient's ecp treatments have now been discontinued, since the patient's condition had started to deteriorate.The customer stated that the patient's ecp treatment procedures did not appear to be improving the patient's lung function.The customer reported that he did feel that patient's ecp treatment procedure contributed to the patient's pulmonary embolism due to the timing of the development of the patient's acute symptoms upon completion of their ecp treatment.However, the customer also felt that the patient's underlying condition and overall health status may have contributed to the patient's pulmonary embolism.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: 8511823
• MDR Text Key: 141922728
• Report Number: 2523595-2019-00054
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2019

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: 03/13/2018
• Initial Date FDA Received: 04/12/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 43