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

Lot Number C111-KIT

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Dyspnea (1816)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Customer called and reported the following: during purging air in double needle mode, pt started coughing; nurse saw air in the tubing all the way from the filter to the pt; and realized air was being sent to the pt.No air detected alarm, the only alarm was return pressure because the pt raised his arms due to coughing.Nurse pressed stop, and saline was sent through the return line.The treatment was aborted and blood returned manually to the pt.Pt kept couching and had difficulty breathing, the nurses did corrective actions: oxygen, head down, feet up, but pt did not seem to improve, they called the cardiac arrest team; the pt recovered and his condition is stable.Pt info: pt is being treated for gvhd, hct: 35:9%, hemoglobin: 114, platelets: 196.Blood pressure before tmt: 119/82, after: 120/82.Heart rate before tmt: 98, after :84.Add'l info about the treatment: treatment was stopped at 434 ml, nurse claimed this was during purging air, collect and return rates were 25 ml/min.The nurse thinks the return bag was not empty at the moment of the event; she estimates that more than 20 but less than 50 ml of air was sent to the pt.No other alarms except the return pressure alarm.Two nurses had checked the kit installation and everything was normal.Smart card is being returned urgently.Update (b)(6): the nurses put the machine out of action after the incident.The kit was discarded after the treatment, no photos are available.Service order (b)(4) was dispatched.

Manufacturer Narrative

Batch record review of lot c111 was conducted.There were no non conformances related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected.Service order (b)(4)completed: therakos specialists completed a full checkout procedure.No faults or errors were seen during checkout.All pumps were recalibrated.However, all were within spec.Air detectors checked multiple times during visit, and worked correctly every time.Checkout form signed and accepted by customer.A therakos field training specialist went on site to deliver operator retraining on (b)(4) 2014.An add'l training session was also offered to the operators in early (b)(4) 2014.The smart card was received analyzed.The operator started the treatment in double needle mode, switched to single needle then back to double.The flow rates were reduced by the operator, and data was recorded to 434ml whole blood processed.Multiple (>10) return air detected and return pressure warnings occurred.So many, that the smart card memory was filled.The operator pressed the end treatment button at the time.Based on the data received, the most likely root cause appears to be poor pt access.Complaints are monitored through tracking and trending.If add'l info is received, the complaint will be reopened and processed accordingly.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOTPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3839232
• MDR Text Key: 4620741
• Report Number: 2523595-2014-00143
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/09/2014

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 Expiration Date: 03/01/2016
• Device Lot Number: C111-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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): Required Intervention