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

Lot Number C125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144)

Event Date 03/11/2015

Event Type  Injury  

Event Description

The clinical services specialist on site for training reported that a patient become unwell during an ecp procedure.Around 750 ml whole blood processed, the patient started complaining about dizziness and looked pale.The patient's blood pressure at the start of the procedure was 141/59 and now it was 80/48.The patient was placed in trendelenburg position.The patient's fluid balance was -137 ml.The procedure was in double needle mode.The patient then reported nausea and started vomiting.At 877 ml whole blood processed, the target was lowered in order to start collecting the buffy coat.Alarm #16: collect pressure occurred a few times, which caused extra pauses.The buffy coat was collected and photoactivation started.The patient recovered and said she felt better than before the procedure.The treatment was completed without further problems.The patient's condition was also fine, with stable parameters.The patient had felt unwell all day, but had not informed the nurses.The patient's crp was elevated: 20.9 mg/l, but the patient had no fever.The physician confirmed that the event was not caused by or related to the ecp treatment.Probably, a norovirus or an upcoming gastritis initiated the symptoms.Also, according to the doctor, some of the patient's medications are known to cause nausea and vomiting.The patient was reported to be in stable condition and has fully recovered.The patient was already hospitalized, with no intention of prolonging the stay.The kit was not returned for evaluation.

Manufacturer Narrative

A batch record review for lot c125 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, hypotension, nausea, vomiting and alarm #16: collect pressure.No trends were detected for complaint categories, hypotension, nausea, vomiting and alarm #16: collect pressure.No capas were initiated for complaint categories, hypotension, nausea, and vomiting, alarm #16: collect pressure was investigated through capa (b)(4).Capa (b)(4) was closed.Based on the internal medical assessment a (b)(6) female with myelodysplastic syndrome, arterial hypertonia, and erosive antral gastritis developed dizziness, pallor, low blood pressure then started to vomit.The patient was placed in trendelenburg position.At that time the patient had a -137 ml fluid balance.The reporter believes that the patient's symptoms are due to gi infection that the patient has.However, since the blood pressure dropped during treatment, there was a negative fluid balance and the patient was put in trendelenburg position.This case is serious and reportable.The assessement 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.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave
• Manufacturer Contact: 10 north high st; suite 300; west chester, PA 19380
• MDR Report Key: 4641021
• MDR Text Key: 20019669
• Report Number: 2523595-2015-00082
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2015

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 Expiration Date: 07/01/2016
• Device Lot Number: C125
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 75 YR
• Patient Weight: 67