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

Lot Number D317 - KIT

Device Problems Bent (1059); Break (1069); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

Customer reported a blood leak occurred in the centrifuge when a single needle mode treatment had reached 1168 ml whole blood processed.Customer stated the patient was stable, had already left the room, and would be returning the next day for another treatment.Customer reported the bowl had broken into three pieces, the drive tube was broken, and a drive tube retainer clip was bent.Clinical services specialist asked if any alarms or unusual noises had occurred prior to the leak.Customer reported collect pressure alarms had occurred earlier in the treatment, and they had worked with the patient's peripheral access to resolve those alarms.Customer stated no unusual noises had preceded the leak.Customer reported that blood had sprayed onto the room wall but had not sprayed onto any person.Service order, (b)(4), was dispatched.The customer returned the smart card and photos of the kit for investigation.Case was updated on (b)(6) 2015: customer called back and reported they had confirmed with their pharmacy that 1,000 units of heparin had been used in the anticoagulant used for this treatment, instead of the standard 10,000 units of heparin.Customer reported this was a pharmacy error, related to the similar appearance of 1,000 unit heparin vials and 10,000 unit heparin vials.Css asked customer if clotting had been observed during this treatment.Customer did not report seeing clotting during the treatment.Customer stated that after the bowl had broken in the centrifuge, some clotting had been observed with the blood that had come out of the bowl, and that this clotting may be visible in some of the photos sent by customer.Customer stated this patient started another ecp treatment on (b)(6) 2016.

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d317 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, centrifuge bowl leak/break, drive tube leak/break, damaged parts/components, alarm #16: collect pressure, clot observed, and medication error.No trends were observed.However, a corrective and preventive action has been initiated for complaint category, drive tube leak/break.A corrective and preventive action was initiated for complaint categories, alarm #16 and damaged parts/components, and is now closed.A corrective and preventive action was initiated for complaint category, centrifuge bowl leak/break.Service order, (b)(4), was completed.The service engineer cleaned blood from the instrument.The centrifuge door was removed and replaced, along with the bowl holder, drive tube clamp assembly, leak strip, drive tube bearing clip, pressure transducer, and drive coupling spider.A water treatment and preventive maintenance were performed.The instrument was placed back in service.This assessment is based on information available at the time of the investigation.Evaluation of the returned smart card and photos is still in progress.A supplemental report will be filed when this analysis is complete.(b)(4).

Manufacturer Narrative

The smartcard and photos were returned for analysis.Based on the review of the smartcard data, prime was completed successfully and the blood collection was started.Several air detected alarms in ac line, a blood pump error alarm, red cell pump alarms and a return pressure alarm were seen.The target for the whole blood processed was adjusted twice.A 1168ml of whole blood was processed.The buffy volume exceeded warning, a blood leak centrifuge alarm and a return pressure alarm occurred.The treatment was aborted without buffy coat collection having been completed.Based on review of photos, the blood leak was confirmed.The outer bowl and the outer bowl cover separated near the weld joint.The photos also show that the upper bearing retainer is open and the lower is closed.The upper retainer could have opened due to the bowl failure or could have been left open at installation.All cover to bowl welding parameters were within the qualified ranges during manufacturing.A material trace of the two components found no nonconformances.Based on the evaluation, the root cause of the bowl break could not be determined.No manufacturing defect could be identified.Review of the device history record did not identify any related nonconformances.This lot had passed all lot release testing.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4905591
• MDR Text Key: 6022597
• Report Number: 2523595-2015-00198
• 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 Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2017
• Device Lot Number: D317 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 43 YR
• Patient Weight: 93