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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR

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ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR Back to Search Results
Model Number OP-08W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Disease, End Stage (2039)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
This incident occurred in (b)(6) and is reported to fda according to the requirement.Plasmaflo op-08w is similar product of plasmaflo op-05w(a) marketed in us, and is used as plasma separator.We reviewed manufacturing records, quality records of lot# mh4z4l.As a result, no abnormality was found in records.1,380 units of this lot# mh4z4l were manufactured, and no similar event using this lot# mh4z4l was reported globally.Physician considered that this event was serious adverse event of "hemolysis", and the causal relationship between this event and plasmaflo op could not be denied.We could not obtain detail information of this event, according to physician's comment, we considered that this event was serious, and that the causal relationship between plasmaflo op and this event could not be denied because the adverse event occurred during the treatment with op-08w.Hemolysis is described in the package insert of plasmaflo op (i.Preface, e.Precautions): 12.Hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13.3kpa).13.Monitor the patient constantly during treatment with the plasmaflo¿ op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.쳌e presence of hemoglobin in separated plasma, due to hemolysis.We will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of adverse events.
 
Event Description
A patient was in the condition of chronic renal failure in (b)(6).The patient was planned to have a kidney-transplant surgery, and double filtration plasmapheresis (dfpp) treatment was required to performed because of the patient's high level of antibodies.(b)(6) 2019: after 10 minutes from the blood was introduced to the circulation of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, bright red liquid was observed in the plasma-room.The doctor thought it may be a hemolysis reaction, and the treatment was stopped.The liquid sample was sent for further test (hemolysis was confirmed).The patient recovered.
 
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Brand Name
PLASMAFLO OP
Type of Device
PLASMA SEPARATOR
Manufacturer (Section D)
ASAHI KASEI MEDICAL CO., LTD.
1-1-2 yurakucho
chiyoda-ku
tokyo 100-0 006
JA  100-0006
Manufacturer (Section G)
ASAHI KASEI MEDICAL MT CORP.
oita works
2111-2 oaza sato
oita-shi, oita 870-0 396
JA   870-0396
Manufacturer Contact
akitake yamashita
1-1-2 yurakucho, chiyoda-ku
tokyo 100-0-006
JA   100-0006
MDR Report Key8435441
MDR Text Key139292618
Report Number8010002-2019-00030
Device Sequence Number1
Product Code MDP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P820033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Model NumberOP-08W
Device Catalogue NumberN/A
Device Lot NumberMH4Z4L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2019
Initial Date FDA Received03/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/21/2018
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 Outcome(s) Other;
Patient Age39 YR
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