MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Misassembled (1398); Material Puncture/Hole (1504); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e356 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, alarm #17: return pressure and tubing leak, and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the returned product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.Device not received for investigation.

Event Description

Customer called to report "punctured" tubing that produced a leak during a procedure earlier in the day.Customer stated it was in the tubing that goes around the recirculation pump and that she believes that it was caused by improper installation of the tubing.Customer reported that saline was noticed on the pump deck after prime but that they thought it was from saline dripped onto the deck from another source.Customer stated the saline was wiped up and treatment proceeded.Customer reported that during recirculation they noticed blood on the pump deck and realized there was a hole in the tubing.Customer stated that they then aborted the treatment with no return to the patient.Customer reported the only alarm was a return pressure alarm and it occurred after they put a towel on the pump deck to catch the spill while the instrument was running and it got caught in the recirculation pump.Customer reported that the patient was stable and that they removed the kit and cleaned the instrument and restarted the treatment.Customer will return the kit for investigation.

Manufacturer Narrative

The kit and smartcard related to this complaint have been investigated.Review of the smartcard data indicated that it is associated with kit lot # e354.The smartcard data did not contain any return pressure warnings but it did have two system pressure alarms and multiple air detected alarms.No holes were founds in the recirculation pump tubing segments of the returned kit.A pressure test had been performed and that did not confirm any leaks.Root cause of the tubing leak and alarm could not be determined.Based on the available information no further action required.Investigation complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage drive po box 9001; po box 9001; hampton, NJ 08827
• MDR Report Key: 6272620
• MDR Text Key: 65942495
• Report Number: 2523595-2017-00017
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E356(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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

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: Nurse
• Device Expiration Date: 10/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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