MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2004-07-08 for NIPRO SET A209/V803 manufactured by Nipro (thailand) Corp. Ltd..
[390270]
Blood leak on nipro bloodline a209/v803 1/2 to 3/4 hours into the patient treatment. Loss of blood estimate at one pint or more on patient and floor. Loss was from venous patient connection to catheter. Venous line changed out and patient continued to run without further problems. Venous line discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2004-00001 |
| MDR Report Key | 610190 |
| Report Source | 05,06,07 |
| Date Received | 2004-07-08 |
| Date Mfgr Received | 2004-06-04 |
| Date Added to Maude | 2005-06-06 |
| 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 | 1072 MOO 8 BANGNOMKO SENA |
| Manufacturer City | AYTHAYA 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 SET |
| Generic Name | BLOOD TUBING SET |
| Product Code | FIB |
| Date Received | 2004-07-08 |
| Model Number | A209/V803 |
| Catalog Number | A209/V803 |
| Lot Number | 03H20 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 599986 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA TH 13110 |
| Baseline Brand Name | NIPRO SET |
| Baseline Generic Name | BLOOD TUBING SET |
| Baseline Model No | A209/V803 |
| Baseline Catalog No | A209/V803 |
| Baseline Device Family | BLOOD SET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K010264 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-08 |