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U.S. Department of Health and Human Services

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

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THERAKOS, INC. THERAKOS CELLEX PHOTOPHORESIS SYSTEM Back to Search Results
Lot Number C359-KIT
Device Problems Leak/Splash (1354); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2015
Event Type  malfunction  
Event Description
The customer reported a drive tube blood leak which occurred when the single needle mode treatment had reached 1401 ml whole blood processed (wbp).The customer aborted the treatment without returning the blood in the kit at that time to the patient.The customer reported that the leak appeared to be coming from a split in the drive tube, at about a 45 degree angle, next to the upper drive tube bearing.The drive tube appeared to be twisted about one-half of a turn.The customer reported that the drive tube was still clamped into the bearing retainers when the treatment was aborted, and that the centrifuge leak sensor strip did not appear to have been damaged.The customer reported a system pressure alarm had occured at about the time of the leak.The customer did not know if a leak alarm had occurred.The customer reported other alarms that occured earlier in the treatment.A red blood cell pump alarm occurred at 400 wbp which had been resolved by stopping, starting, and slowing the collect rate, and a return pressure alarm which was resolved early in the treatment, which had been caused by patient movement.15000 units of heparin in 500 ml saline was used as the anticoagulant in this treatment.The patient was reported to be in stable condition.Service order, (b)(4), was generated and the kit along with photos were returned for evaluation.
 
Manufacturer Narrative
A batch record review of lot c359 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, drive tube leak/break, alarm #18: system pressure, alarm #45: red blood cell pump alarm and alarm #17: return pressure.No trends were detected for complaint categories, drive tube leak/break and alarm #17: return pressure.An upward trend was detected for complaint categories, alarm #18: system pressure and alarm #45: red blood cell pump alarm.Drive tube leak/break was investigated through capa (b)(4) and capa (b)(4).Capa (b)(4) was closed.Alarm #18: system pressure, alarm #45: red blood cell pump alarm, and alarm #17: return pressure were investigated through capa (b)(4).Capa (b)(4)was closed.Alarm #18: system pressure and alarm #45: red blood cell pump alarm were also investigated through capa (b)(4).Capa (b)(4) was closed.Service order, (b)(4), feedback: the customer had cleaned the machine and the service technician cleaned the surfaces where blood commonly pools such as behind the panels and such.The technician performed the checkout procedure and all tests passed per specifications.The technician also adjusted the pressure transducers and load cells per documentation.The technician tested the machine and no errors were found.No further action required.This assessment is based on information available at the time of the investigation.The kit and photos were returned for evaluation.Analysis of the kit and photos is in progress.A supplemental report will be filed when this analysis is completed.(b)(4).
 
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Brand Name
THERAKOS CELLEX PHOTOPHORESIS SYSTEM
Type of Device
CELLEX
Manufacturer (Section D)
THERAKOS, INC.
west chester PA
Manufacturer (Section G)
HARMAC MEDICAL PRODUCTS
2201 baily ave.
buffalo NY 14211
Manufacturer Contact
10 north high st.
suite 300
west chester, PA 19380
MDR Report Key4535784
MDR Text Key18091937
Report Number2523595-2015-00043
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 01/29/2015
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 Date11/01/2016
Device Lot NumberC359-KIT
Other Device ID Number10705030100009
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/09/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
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 Age75 YR
Patient Weight66
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