MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Expulsion (2933)

Patient Problem Blood Loss (2597)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the pressure dome membrane leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot e361 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e361 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure and pressure dome membrane leak.No trends were detected for these complaint categories.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.(b)(4).

Event Description

The customer called to report a system pressure dome membrane leak during the phase two "elutriation" stage of the buffy coat collection during a treatment procedure.The customer stated that they received an alarm #18: system pressure alarm during the elutriation phase of the treatment, and then the system pressure dome "popped off" its pressure transducer and leaked onto the pump deck.The customer reported that they aborted the treatment with no return of blood/products to the patient.The customer stated that the patient was in stable condition after the aborted treatment and was still in stable condition at the time of discharge.The customer reported that the patient's fluid balance was -97mls at the time the treatment was aborted.The customer stated that no medical intervention was performed and no blood transfusion or saline bolus was ordered for the patient due to the aborted treatment.The customer reported that the patient's single lumen vortex port was "tpa'd" prior to the procedure.The customer stated that the patient's platelet count was "normally in the 400s", however, during this treatment the patient's platelet count was in the "900s." the kit was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6386152
• MDR Text Key: 69625790
• Report Number: 2523595-2017-00043
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E361(17)181001
• 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: Other
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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 Age: 23 YR
• Patient Weight: 63