MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-02 for BD BACTEC FX - TOP UNIT 441385 manufactured by Bd Diagnostic Systems.
[19936054]
The bactec fx is composed of multiple row boards which read the bottles to determine growth in the blood culture vial. In this event, the defective row board was returned to bd for investigation. Investigation into the row board failure was initially able to duplicate the led failure which caused a zero reading. Component level fault has not been isolated as the component is now working and has not failed again. In the software for this instrument, there is an algorithm that applies only to anaerobic media. This algorithm prevents false negatives from hydrogen sulfide (hs) producing organisms. This algorithm did not allow for a zero reading. When a combination of events occur, the zero read failure occurs independently in a row board and an anaerobic bottle is in the station, it caused a zero reading in the station. The hs algorithm, which does not account for zero readings, caused the instrument to not recognize a bottle was present in the system. If the zero read failure occurs in combination with another type of board failure, or in the presence of an aerobic culture vial, the algorithm would allow the instrument to identify presence of a bottle and alarm the customer to move the bottle to another station. If the bottle has not been read for greater than 40 minutes, the customer is instructed to smear and subculture the bottle. Based on the number of boards in the field and failures to date, the estimate that this issue would occur a second time is 0. 01%. Additionally, based on how customers use the product, of the devices that may malfunction, the likelihood that this would cause an injury is 0. 00025%. A software revision is being developed, tested and duplicated to be released to the field. Bd will continue to closely monitor this situation.
Patient Sequence No: 1, Text Type: N, H10
[19959575]
Customer was placing blood culture vials into the bactec fx. When the instrument went to read the vials, it detected bad stations and alarmed for the aerobic bottle. The customer immediately moved the vials to another station and blocked the bad stations. Two days later, the customer noticed that the anaerobic mates to those aerobic culture vials were still in the original rack. The customer pulled the growth plots and noted there were no readings for these vials. Vials were removed from the instrument, gram stained and subcultured. No growth was observed on the subculture and no organism seen on the gram stain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2009-00009 |
| MDR Report Key | 1526916 |
| Report Source | 05 |
| Date Received | 2009-11-02 |
| Date of Report | 2009-10-29 |
| Date of Event | 2009-10-07 |
| Date Mfgr Received | 2009-10-07 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2010-03-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2009-11-02 |
| Returned To Mfg | 2009-10-19 |
| Catalog Number | 441385 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-11-02 |