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

Lot Number E312-KIT

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e312 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The uvadex lot number was not provided as it was not administered.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, shortness of breath and increased blood pressure.No trends were detected for these complaint categories.The patient's hypertension and respiratory distress occurred prior to the administration of uvadex and the treatment was aborted immediately after the hypertension and respiratory distress occurred.Therefore, this is not reportable from a drug perspective.From a device perspective, there was no device malfunction.It is probable that this was an effect of the patient's underlying pneumonia.However, since it can not be ruled out that the device or procedure could have contributed to the patient's hypertension and respiratory distress and that medical intervention was required, this case will be reported as an mdr.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.Adverse event terms: hypertension, respiratory distress, and oxygen saturation, low (b)(4).Device not returned to manufacturer.

Event Description

The customer called to request assistance in ending a procedure due to the patient not tolerating the treatment.The customer reported that they had processed 679 ml of whole blood and that the treatment was currently paused.The customer stated that the patient's blood pressure was 221/140 and that the patient had complained of breathing difficulties.The customer reported that a rapid response team was called.The customer stated that they want to remove the patient's peripheral access and disconnect the patient with no blood/product returned to the patient.The customer was advised to press "abort treatment".The customer reported that they were able to end the treatment.On (b)(6) 2016, the customer stated that the patient had a history of graft versus host disease following a bone marrow transplant three months ago.The customer reported that the patient had been in the inpatient unit with a pneumonia diagnosis.The customer stated the patient had received a packed red blood cell transfusion overnight and a platelet transfusion immediately before the start of the extracorporeal photopheresis treatment.The customer reported that the patient's hematocrit (hct) was 26% prior to the transfusion and 29% following the transfusion.The customer stated that they had performed the extracorporeal volume (ecv) calculations and that the patient was deemed appropriate for treatment.The customer reported that the patient's baseline blood pressure and heart rate were 152/101 and 142, respectively.The customer stated that the patient's baseline oxygen saturation was 95% on 3l of oxygen.The customer reported that the treatment was proceeding smoothly in single needle mode with a peripheral access until the patient was put on a bedpan and stated, "i can't breathe." the customer stated that the patient's oxygen saturation had dropped to 82% and that the patient's blood pressure rose to 222/140.The customer reported that the patient's oxygen was then turned up to 6l and administered via a face mask.The customer stated that the treatment was stopped immediately with no volume from the treatment returned to the patient.The customer reported that a chest x-ray was obtained and both lasix and ativan were administered to the patient.The customer stated that the patient was in stable condition when the customer left.The kit was not returned for investigation as it had already been discarded.

• 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: 5742722
• MDR Text Key: 47967504
• Report Number: 2523595-2016-00153
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2016

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: Nurse
• Device Expiration Date: 03/01/2018
• Device Lot Number: E312-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 54