MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-26 for BD BACTEC FX - TOP UNIT 441385 manufactured by Bd Diagnostic Systems.
[1423899]
A customer recently had a bactec fx instrument partially installed in the laboratory. The customer had a "stack" configuration which is 2 units stacked one on top of the other. When the customer opened a fully loaded drawers from each unit the stack began to move forward and start to topple. Another tech was close by and assisted to stabilize the instrument avoiding any injury to either tech.
Patient Sequence No: 1, Text Type: D, B5
[8514838]
The bactec fx instrument was designed to meet (b)(4), ul and int'l stability regulations. After proper installation, all saleable configurations of the bactec fx, using worst case scenarios including the one described in this report, were tested for overbalancing (tipping over). Each configuration passed all criteria. The instrument has wheels that allow for easy transportation during installation. Once the instrument reaches the installation location, all four instrument feet should be completely extended to make contact with the floor to become the load bearing components of the instrument's weight and then the instrument is leveled. The wheels should not bear any weight and will spin freely once the feet are properly placed. The service engineer who installed the instrument did not complete the required install check list from the bd bactec fx system installation procedure. It is unclear whether the unit was not properly set up during install or was altered/moved by the customer. The instrument still had one wheel in contact with the ground and only three feet were properly placed and leveled. Multiple warning appears in the current installation procedure used by the engineer to install the unit as well as the customer user's manual. Customers are instructed to contact bd prior to moving the unit. Engineers will be retrained to the current procedure, training will be documented and effectiveness will be evaluated. This corrective action is being documented within the capa system. Bd will continue to closely monitor this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2010-00001 |
| MDR Report Key | 1619871 |
| Report Source | 05 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-01-26 |
| Date Mfgr Received | 2010-01-27 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2011-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES TILLMAN |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BACTEC FX - TOP UNIT |
| Product Code | JTA |
| Date Received | 2010-02-26 |
| Catalog Number | 441385 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-26 |