MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-05-16 for ACS:180 SE * manufactured by Kmc Systems Inc..
[389404]
In 2005 bayer received a report of a customer who got a metal splinter while troubleshooting an acs:180 instrument. A user of the acs: 180 was performing a cleaning procedure when they recieved a vaccul low error from this patient. In an effort to troubleshoot the problem and following instructions for use, the customer checked the seals on the waster container adnd checked the water trap for fluid, the trap had fluid, the trap had fluid. Customer removed adn cleaned the water trap and restalled it. While attempting to tighten the cap to the water trap a brass filing from the fitting penetrated their finger. Customer had the filing removed immediately and sought medical attention. This event happened in a biohazardous environment and there is a potential of biohazard exposure for that reason it is being reported. For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00009 |
| MDR Report Key | 603438 |
| Report Source | 05,06 |
| Date Received | 2005-05-16 |
| Date of Report | 2005-04-25 |
| Date of Event | 2005-04-24 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2005-05-19 |
| 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 | ANDRES HOLLE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243494 |
| Manufacturer G1 | KMC SYSTEMS INC. |
| Manufacturer Street | * |
| Manufacturer City | MERRIMACK NH * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACS:180 SE |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | LCI |
| Date Received | 2005-05-16 |
| Model Number | ACS:180 SE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 593274 |
| Manufacturer | KMC SYSTEMS INC. |
| Manufacturer Address | * MERRIMACK NH * US |
| Baseline Brand Name | ACS:180 SE |
| Baseline Generic Name | IMMUNOASSAY SYSTEM |
| Baseline Model No | ACS:180 SE |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-16 |