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

Lot Number E301-KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Hypoxia (1918)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e301 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) 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, pressure dome membrane leak, alarm #18: system pressure, and alarm #17: return pressure.No trends were detected for these complaint categories.The patient's hypoxic episode occurred prior to the administration of (b)(4) and the treatment was aborted immediately after the observation of the pressure dome leak.Therefore, this is not reportable from a drug perspective.From a device perspective, there was a device malfunction; a pressure dome membrane leak.Due to the device malfunction and since the patient's hypoxic episode occurred during treatment and medical intervention with oxygen was needed, as well as hospitalization; this case is reportable as a mdr.The kit and smart card were received for analysis.A review of the smart card data confirmed the occurrence of alarm #18: system pressure and alarm #17: return pressure alarms.A review of the kit components confirmed the presence of dried blood on the body of the system pressure dome.An evaluation of the kit components found that the system pressure dome's diaphragm was fully seated onto the body of the pressure dome.A visual examination of the system pressure dome found no molding defects on any part of the pressure dome's body.The system pressure dome was installed on a pressure sensor in the lab in order to check for any unseen fit issues.The system pressure dome fit onto the pressure sensor without any issues and both pressure dome latches could be seated in their circumferential groove without any added effort.The system pressure dome was pressure tested in order to check for leaks.Pressure testing did not find any leaks in the system pressure dome, even though the visual examination of the pressure dome indicated that blood had leaked from it.The centrifuge bowl was tested in order to try and determine the source of the alarm #18: system pressure alarms.The testing of the centrifuge bowl did not indicate an issue with the kit that could have resulted in the alarm #18: system pressure alarms.Therefore, no manufacturing related defects with the kit were confirmed during the evaluation.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 term: hypoxia.(b)(4).

Event Description

The customer called to report a system pressure dome blood leak during a treatment procedure.The customer stated that at about 200 ml of whole blood processed there was an alarm #18: system pressure alarm.The customer reported that they were able to reset the alarm and continued with the treatment procedure.The customer stated that at about 1289 ml of whole blood processed there was another alarm #18: system pressure alarm, and then the system pressure dome came off and leaked onto the pump deck and transducer.The customer reported that the patient's line was clamped and the patient was disconnected from the instrument.The treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was exhibiting signs of hypoxia.The customer reported that the patient was laying down at the moment and was being administered oxygen via a nasal canula.The customer stated that the patient was transferred to the emergency room.The customer reported that the patient did not express any complaints about not feeling well prior to the start of the procedure.The customer stated that their biomed engineer will check the instrument.On april 25, 2016, the customer stated that the patient had a history of pneumonia.The patient's estimated blood loss was determined to be approximately 250ml.The customer reported that the patient was stable and had been discharged from the hospital.The kit and smart card were received for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5612784
• MDR Text Key: 43848058
• Report Number: 2523595-2016-00113
• 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: 04/01/2016

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?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2018
• Device Lot Number: E301-KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 59