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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

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TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER Back to Search Results
Catalog Number 1BBWGQ506A2
Device Problems Defective Component (2292); High Test Results (2457); Filtration Problem (2941)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation is in process.A follow up report will be provided.
 
Event Description
The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.There was not a transfusion recipient or patient involved at the time of whole blood processing,therefore no patient information is reasonably known at the time of the event.Donor unit#: (b)(4).
 
Manufacturer Narrative
One set of blood bags with the filter from the collection set was returned for evaluation.The leukoreduction filter was tested for flow rate and air leaks.A relatively slow flow rate of 10ml/min was noted and it was confirmed there were no air leaks.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.All membranes conformed to established specification.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be due to an occlusion, blood may have been filtered by a smaller than usual filter area.As a result, linear speed may have increased and leukocyte leakage may have occurred.As an increase of wbc contamination complaints were noted from previous lot numbers, further investigation was performed.Investigation results indicated that the cause of higher-than-expected wbc content in the whole blood product was due to the maximum pore size of the filter membrane is likely to increase according to the combination of multiple parameters in manufacture of leukoreduction filter membranes and wbc contamination is likely to occur frequently in the product lots of which the maximum pore size of the filter membrane has increased.The instructions for use provide a caution to not squeeze or apply pressure to the filter while it is attached to the bag containing the filtered blood and also to clamp the blood filled tubing before blood enters the filter in order to avoid leukocyte leakage.Corrective action: an internal capa has been initiated to review the maximum pore size of the filter membrane and the likelihood of an increase according to the combination of the multiple parameters.In addition, the wbc contamination is likely to occur frequently in the product lots of which the maximum pore size of the filter membrane has increased.To achieve a resolution, manufacturing specifications were updated to narrow the range of the parameters in the manufacture of filter membranes and it was confirmed that the appropriate level of the maximum pore size of the filter membrane was achieved.
 
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Brand Name
IMUFLEX BLOOD BAG SYSTEM
Type of Device
IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
Manufacturer (Section D)
TERUMO CORPORATION
fujinomiya
MDR Report Key8010822
MDR Text Key126550777
Report Number9681839-2018-00054
Device Sequence Number1
Product Code CAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/26/2018
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 Date05/31/2020
Device Catalogue Number1BBWGQ506A2
Device Lot Number171204KK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/04/2018
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer10/26/2018
Initial Date Manufacturer Received 10/04/2018
Initial Date FDA Received10/26/2018
Supplement Dates Manufacturer Received11/09/2018
Supplement Dates FDA Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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