MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-01 for BD TRIAC CENTRIFUGE 420200 manufactured by The Drucker Company.
[3294946]
A customer was placing specimens inside the triac centrifuge when the unit started to spin with the lid in the open position. The user immediately withdrew their hand and turned off the unit. The unit was boxed up for return for investigation. The user had purchased the unit and rec'd it on (b)(6) 2013 and had successfully used the instrument without incident until this day.
Patient Sequence No: 1, Text Type: D, B5
[10810601]
The bd triac centrifuge is a multi-speed, table-model centrifuge designed to operate in the following three modes: mhct mode: to obtain quantitative micro-hematocrits from whole blood. Blood mode: to obtain urine sedimentations for microscopic examination. The centrifuge is equipped with a lid safety switch. When the lid is closed and properly latched, a safety witch is engaged, activating the motor. The centrifuge was returned to bd for investigation. It was confirmed that the centrifuge did spin with the lid in the open position. It was determined that the actuator spring was jammed onto, and to the side of the safety switch. When the jam was released the instrument began functioning as intended. During assembly the operation of the safety switch is confirmed for 100% of the units manufactured. The device history record was reviewed. All parts and construction processes were following accordingly. Complaint trending was performed. There is no trend on this type of defect noted. No further action will be taken at this time as this appears to be an isolated event. Bd will continue to trend on this type of event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00004 |
| MDR Report Key | 3101832 |
| Report Source | 05 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-01 |
| Date of Event | 2013-04-01 |
| Date Mfgr Received | 2013-04-01 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-07-09 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAROLTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | THE DRUCKER CO |
| Manufacturer Street | 200 SHADYLANE DR |
| Manufacturer City | PHILIPSBURG PA 16866 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 16866 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD TRIAC CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2013-05-01 |
| Returned To Mfg | 2013-04-11 |
| Model Number | 420200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE DRUCKER COMPANY |
| Manufacturer Address | PHILIPSBURG PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-01 |