ASAHI AM-BIO SERIES DIALYZERS AM-BIO-100 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2003-04-14 for ASAHI AM-BIO SERIES DIALYZERS AM-BIO-100 NA manufactured by Asahi Medical Co., Ltd..

Event Text Entries

[19891367] The dialyzer was at the 6th reuse. The leak was observed with leak detector. Blood loss volume was around 200cc, since the blood was not returned to the patient. The patient was well and no medical treatment was given to the patient. Other cases of leak were reported from this facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010002-2003-00026
MDR Report Key454456
Report Source06,08
Date Received2003-04-14
Date of Report2003-04-14
Date of Event2003-03-18
Date Mfgr Received2003-03-26
Device Manufacturer Date2002-11-01
Date Added to Maude2003-04-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactMR. SEIICHI IIJIMA, GENERAL MANAGER
Manufacturer Street9-1, KANDA MITOSHIROCHO CHIYODA-KU
Manufacturer CityTOKYO 101-8482
Manufacturer CountryJA
Manufacturer Postal101-8482
Manufacturer Phone32595892
Manufacturer G1ASAHI MEDICAL OITA PLANT
Manufacturer Street2111-2 OAZA SATO OITA-CITY
Manufacturer CityOITA-PREFECTURE
Manufacturer CountryJA
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameASAHI AM-BIO SERIES DIALYZERS
Generic NameHEMODIALYZER
Product CodeMSE
Date Received2003-04-14
Model NumberAM-BIO-100
Catalog NumberNA
Lot Number72Y6YA
ID NumberNA
Device Expiration Date2005-11-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key443458
ManufacturerASAHI MEDICAL CO., LTD.
Manufacturer Address9-1, KANDA MITOSHIROCHO CHIYODA-KU, TOKYO JA 101-8482
Baseline Brand NameASAHI AM-BIO SERIES DIALYZERS
Baseline Generic NameHEMODIALYZER
Baseline Model NoAM-BIO-100
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyASAHI AM-BIO SERIES DIALYZER
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]36
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK983720
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-04-14

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