MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-15 for NIPRO A217/V806 manufactured by Nipro Medical Corporation..
[422524]
Report was received in 07/2005 that blood tubing leaked 50-75 cc blood at pump segment connector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2005-00001 |
| MDR Report Key | 627414 |
| Report Source | 05,06 |
| Date Received | 2005-08-15 |
| Date of Report | 2005-08-02 |
| Date of Event | 2005-06-17 |
| Date Mfgr Received | 2005-07-12 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2005-08-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CARY GOLDSMITH |
| Manufacturer Street | 3150 NW 107 AVE. |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 3055997174 |
| Manufacturer G1 | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Street | 10/2 MOO 8, BANGNOMKO, SENA |
| Manufacturer City | AYUTHAYA 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPRO |
| Generic Name | DIALYSIS BLOOD LINES |
| Product Code | FIB |
| Date Received | 2005-08-15 |
| Model Number | A217/V806 |
| Catalog Number | A217/V806 |
| Lot Number | 04K29 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 617042 |
| Manufacturer | NIPRO MEDICAL CORPORATION. |
| Manufacturer Address | * * TH |
| Baseline Brand Name | NIPRO |
| Baseline Generic Name | DIALYSIS BLOOD LINES |
| Baseline Model No | A217/V806 |
| Baseline Catalog No | A217/V806 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-15 |