ASAHI AM-BIO SERIES DIALYZER 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 report with the FDA on 2005-04-22 for ASAHI AM-BIO SERIES DIALYZER AM-BIO-100 NA manufactured by Asahi Kasei Medical Co., Ltd..

Event Text Entries

[368399] Two leaks of saline solution from attachment point of header occurred during the priming before analysis treatment. Because they did not enter dialysis with these devices, the blood loss was none. The patients were well and no medical treatments were given. The lot in complaint is the same lot in recall (recall no. 8010002-3/28/05-001-r).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010002-2005-00011
MDR Report Key597703
Report Source06
Date Received2005-04-22
Date of Report2005-04-22
Date of Event2005-03-22
Date Mfgr Received2005-04-01
Device Manufacturer Date2004-07-01
Date Added to Maude2005-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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
Manufacturer CityOITA-CITY, OITA-PREFECTURE
Manufacturer CountryJA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASAHI AM-BIO SERIES DIALYZER
Generic NameHEMODIALYZER
Product CodeMSE
Date Received2005-04-22
Model NumberAM-BIO-100
Catalog NumberNA
Lot Number046P72-S
ID NumberNA
Device Expiration Date2007-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key587536
ManufacturerASAHI KASEI 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
10 2005-04-22

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