MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-04-05 for LASERFLO BPM2 SAME manufactured by Vasamedics.
[234608]
In or about 2001 the bpm2 monitor was used with its accessories postoperatively to monitor blood flow on a tram breast reconstruction at hospital. The pt had very pale abdominal skin during monitoring. The bpm2 registered blood flow values between 0. 85 and 1. 3 flow units. This flow level range is considered by most bpm2 users, including the attending surgeon, to be at the margin between acceptable and poor, and readings below 1. 0 generally indicate the need for close surveillance. The tissue had a good appearance for some hours after surgery, but on the following morning its appearance was poor, while blood flow readings remained in the same range as before. Salvage of the reconstruction was not possible. No other complications were reported, and the pt has apparently had no other adverse results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183929-2001-00001 |
| MDR Report Key | 325977 |
| Report Source | 05,06 |
| Date Received | 2001-04-05 |
| Date of Report | 2001-04-04 |
| Date of Event | 2001-02-01 |
| Date Mfgr Received | 2001-03-06 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 2001-04-12 |
| 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 Street | 2958 YORKTON BLVD. |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6514900999 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASERFLO |
| Generic Name | BLOOD FLOW MONITOR |
| Product Code | DPW |
| Date Received | 2001-04-05 |
| Returned To Mfg | 2001-03-06 |
| Model Number | BPM2 |
| Catalog Number | SAME |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 315430 |
| Manufacturer | VASAMEDICS |
| Manufacturer Address | 2958 YORKTON BLVD. ST. PAUL MN 55117 US |
| Baseline Brand Name | LASERFLO BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Generic Name | LASER DOPPLER BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Model No | BPM2 |
| Baseline Catalog No | BPM2 |
| Baseline ID | BPM2 MONITOR AN |
| Baseline Device Family | LASER DOPPLER BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K912446 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-04-05 |