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

Lot Number E324-KIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Tachycardia (2095)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e324 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Uvadex lot# ae0046 (manufacture date: 04/07/2015 and expiration date 03/31/2018) was reviewed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #45: red blood cell pump alarm, hypotension, heart rate increase, and central line infection.No trends were detected for these complaint categories.From a device perspective, there is no known device malfunction.However, since the physicians were not able to rule out ecp as a possible cause for the central line infection and the device may have contributed to the spread of the infection, this case is being reported out of an abundance of caution.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.Adverse event terms: hypotension, tachycardia, and infection.(b)(4).Device not returned to manufacturer.

Event Description

On (b)(6) 2016, the customer reported that an alarm #45: red blood cell pump alarm occurred after approximately 360 ml of whole blood processed.The customer stated that they were able to force the buffy coat at this point.The customer reported that the patient had been intubated prior to the extracorporeal photopheresis (ecp) procedure, but the reason for this incubation was not stated.The customer stated that the patient experienced both hypotension and tachycardia during reinfusion, which was at a rate of 5 ml/minute.The customer supplied flow sheet of the patient's ecp treatment showed that the patient started out with a low blood pressure and the medical professionals were fine with the mean arterial pressure (map) staying at or greater than 50.The flow sheet indicated that the patient's tachycardic event occurred when the patient's heart rate spiked into the 180s during the blood return.There was no medical intervention reported for the patient, although the patient's flow sheet did state that the medical team was present at the patient's bedside.The tachycardia appeared to have spontaneously resolved on its own, according to the patient's ecp flow sheet.The customer stated that the treatment was completed with a treatment volume of 127 ml ,and the patient's ending fluid balance was +154 ml.The customer also reported that the patient had an infected/septic line due to aseptic techniques, however it was unclear if the infection occurred prior to or during the ecp treatment.The customer stated that the hospital discovered that the patient's line was septic after a (b)(6) 2016 culture came back positive.The customer stated that the patient was started on antibiotics later that day.The customer reported that it is unknown when the line became septic or who exactly had been accessing the line (the patient was in picu).The customer stated that the central line had been placed approximately one week prior to the ecp treatment.The kit was not returned for investigation.

• 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: 5918753
• MDR Text Key: 53664431
• Report Number: 2523595-2016-00193
• 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: 08/02/2016

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: 05/01/2018
• Device Lot Number: E324-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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 Weight: 11