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

Lot Number R.N.P.

Device Problems Device Alarm System (1012); Detachment Of Device Component (1104); Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

Customer reported a return pressure alarm occurred after a blood prime treatment was completed and would not clear.Css advised customer on how to release pressure by connecting the collect and return lines and unloading the collect and return pump tubing segments.Customer stated one of the pressure domes came off and leaked blood onto the pump deck.Css asked if customer was splashed with blood/fluids.Customer stated some blood splashed onto her scrubs, but her skin was not exposed to any fluids.Css suggested customer carefully check and report to her facility's health services.Customer agreed to do so.Css walked customer through aborting the treatment procedure.Service order (b)(4) was dispatched.

Manufacturer Narrative

No lot number provided, therefore batch record review could not be performed.Trends have been reviewed for this complaint category and no trends have been detected for pressure dome membrane leak.Capas (b)(4) have already been initiated to investigate these type of events.Service order (b)(4) was completed: service engineer cleaned up blood spill around the lower pressure transducers.Performed system checkout; all ok.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.(b)(4).

• Brand Name: THERAKOS CELLEX SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: therakos ; 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4063482
• MDR Text Key: 17990179
• Report Number: 2523595-2014-00216
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2014

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: Health Professional
• Device Lot Number: R.N.P.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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