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U.S. Department of Health and Human Services

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

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THERAKOS, INC. THERAKOS CELLEX SYSTEM Back to Search Results
Lot Number C322-KIT
Device Problems Break (1069); Leak/Splash (1354); Component Missing (2306); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2014
Event Type  malfunction  
Event Description
Customer reported: the kit had completed priming normally, then the bowl holder shortly after a single needle mode treatment started, at about 205 ml whole blood processed, during the initial purging air phase.An alarm occurred but the specific alarm could not be recalled.Customer had re-installed the bowl into the bowl holder and restarted the treatment.The bowl then came out of the bowl holder again, and this time the drive tube was severed close to the drive tube clamp assembly and the centrifuge leak sensor strip was damaged.The treatment was aborted and no blood was returned to the patient.When the instrument was powered on later, a system error 130 occurred.The black locking tab on the bowl holder appears to be in good operating condition.The sensorized drive tube clamp assembly might have been damaged.One of the plastic tabs at the base of the bowl is now intact, one is missing, and one is partially missing.Patient is stable and has started a new treatment on a different instrument.Service (b)(4) was dispatched.Customer will return product for evaluation.
 
Manufacturer Narrative
A review of lot c322 was conducted.There were no nonconformances associated with this type of failure for this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for centrifuge bowl leak no for drive tube leaks; capa's (b)(4) have already been initiated to investigate centrifuge bowl leaks and drive tube leaks.Service order (b)(4) completed: service engineer replaced leak detector strip and performed checkout procedure according to service manual.No further action required.The assessment is based on information available at the time of the investigation.The product return evaluation is still in progress at the time of this report; therefore, final investigation findings are still pending.
 
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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
440 us route 22 east
suite 140
bridgewater, NJ 08807
MDR Report Key4174627
MDR Text Key22002154
Report Number2523595-2014-00210
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P680003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/16/2014
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 Date05/01/2016
Device Lot NumberC322-KIT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/24/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2014
Initial Date FDA Received08/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age26 YR
Patient Weight78
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