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..
[302068]
Blood leaks occurred after start of hemodialysis treatment. The leak was observed with leak detector. The blood loss volume was around 150cc. The dialysis center reported blood leaks occurred in five different lots for 9 patients. However, the number of patients and products involved in each concerned lot are unknown. The dialyzers were at the 2nd - 14th reuse. Patients were well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010002-2003-00035 |
| MDR Report Key | 470699 |
| Report Source | 06,08 |
| Date Received | 2003-07-04 |
| Date of Report | 2003-07-04 |
| Date of Event | 2003-05-28 |
| Date Mfgr Received | 2003-06-05 |
| Device Manufacturer Date | 2003-02-01 |
| 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 LIJIMA, 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 | 732A2H-E |
| ID Number | NA |
| Device Expiration Date | 2006-02-17 |
| 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 | 459539 |
| Manufacturer | ASAHI MEDICAL CO., LTD. |
| Manufacturer Address | 9.-, 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 |