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

Lot Number C317 - KIT

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

Customer reported the centrifuge bowl broke and leaked blood in the centrifuge as the treatment was starting the recirculation/purging phase after prime and initial air purge had been completed.The base of the bowl separated from the sidewall of the bowl.The treatment was aborted.Customer stated the instrument display indicated the pt's fluid balance was negative 120 ml.Customer stated the pt hematocrit had dropped from 34.5 per-treatment to 33.5 post-treatment.No follow up fluids had been given to the pt, pt is stable.Service order # (b)(6) was dispatched.Customer returned smart card and provided photos for investigation.

Manufacturer Narrative

Batch record review of lot c317 was conducted.There were no non conformances related to this lot.Lot met release requirements.Trends were reviewed for these complaint categories and no trends have been detected.However, capa (b)(4) was initiated to investigate centrifuge bowl leak/break.Service order (b)(4) completed: service engineer performed system checkout and release unit to customer.The assessment is based on info available at the time of the investigation.The smart card and photo eval are still in progress at the time of this report; therefore, final investigation findings are still pending.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOTPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e, ste 140; bridgewater, NJ 08807
• MDR Report Key: 3983395
• MDR Text Key: 4821735
• Report Number: 2523595-2014-00184
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/12/2014

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: 04/01/2016
• Device Lot Number: C317 - KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 Age: 13 YR
• Patient Weight: 38