MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-04 for ADVANCED VENOUS ACCESS M3L9FHKI NA manufactured by Edwards Lifesciences.
[21257667]
It was reported that blood was filling the contamination shield during open cardiac chest massage. It was reported that the patient later expired. The relationship of the device to the patient's expiration is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-2001-00162 |
| MDR Report Key | 330797 |
| Report Source | 05 |
| Date Received | 2001-05-04 |
| Date of Report | 2001-04-04 |
| Report Date | 2001-04-04 |
| Date Mfgr Received | 2001-04-04 |
| Date Added to Maude | 2001-05-09 |
| 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 | 3 |
| Manufacturer Contact | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED VENOUS ACCESS |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | JCY |
| Date Received | 2001-05-04 |
| Model Number | M3L9FHKI |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 320159 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ROAD 402 NORTH KM 1.0 ANASCO PR 00610 US |
| Baseline Brand Name | ADVANCED VENOUS ACCESS (AVA) CATHETER |
| Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Baseline Model No | M3L9FHKI |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981909 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-04 |