MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2003-07-04 for ASAHI AM-BIO SERIES DIALYZERS AM-BIO-100 NA manufactured by Asahi Medical Co., Ltd..
[321980]
Blood leaks occurred after start of hemodialysis treatment. The blood loss volume was not reported. The dialysis center reported that blood leaks occurred in five different lots for 9 patients. However, the number of patients and products involved in each concerned lot is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2003-00037 |
| MDR Report Key | 470709 |
| Report Source | 06,08 |
| Date Received | 2003-07-04 |
| Date of Report | 2003-07-04 |
| Date of Event | 2003-05-28 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2003-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. SEIICHI IIJIMA, GENERAL MANAGER |
| Manufacturer Street | 9-1, KANDA MITOSHIROCHO CHIYODA-KU |
| Manufacturer City | TOKYO 101-8482 |
| Manufacturer Country | JA |
| Manufacturer Postal | 101-8482 |
| Manufacturer Phone | 32595892 |
| Manufacturer G1 | ASAHI MEDICAL OITA PLANT |
| Manufacturer Street | 2111-2 OAZA SATO OITA-CITY |
| Manufacturer City | OITA-PREFECTURE |
| Manufacturer Country | JA |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI AM-BIO SERIES DIALYZERS |
| Generic Name | HEMODIALYZER |
| Product Code | MSE |
| Date Received | 2003-07-04 |
| Model Number | AM-BIO-100 |
| Catalog Number | NA |
| Lot Number | 42XZXN-G |
| ID Number | * |
| Device Expiration Date | 2005-10-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 459549 |
| Manufacturer | ASAHI MEDICAL CO., LTD. |
| Manufacturer Address | 9-1, KANDA MITOSHIROCHO CHIYODA-KU, TOKYO JA 101-8482 |
| Baseline Brand Name | ASAHI AM-BIO SERIES DIALYZERS |
| Baseline Generic Name | HEMODIALYZER |
| Baseline Model No | AM-BIO-100 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | ASAHI AM-BIO SERIES DIALYZER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K983720 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-04 |