MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-19 for BD MAX INSTRUMENT 441916 manufactured by Bd Diagnostic Sys.
[4244923]
A bd application specialist was on-site performing training and noted that the bd max instrument door was very hard to push up and slams down. The application specialist contacted the bd technical service and support department for an engineer to be dispatched for repair. A field service engineer found that the spring had a broken pin causing it to no longer be connected. The fse repaired and tested the door. The door is now functioning as intended. The bd max system is intended for in vitro diagnostic (ivd) use in performing nucleic acid testing in clinical laboratories. The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequenced by fluorescence-based pcr.
Patient Sequence No: 1, Text Type: D, B5
[11606770]
The device did not lead to death or serious deterioration in the health of a pt or user; however, info does suggest that if the device malfunction were to recur, it could contribute to an injury. The bd quality dept investigated the complaint of the bd max instrument door being difficult to open and slamming down. The complaint was confirmed by the field service engineer on-site. The investigation of the returned parts found that one of the two steel pins in the door hinge plate was sheared off. In addition, the bolt that holds the gas spring occurred at some point previous to this failure. Investigation is unable to determine when this occurred. Improper assembly would result in a misalignment and an unseen load being placed on the pins/bolts of the hinge assembly. The aforementioned load on the pins/bolts would eventually cause this failure. The door hinge assembly was replaced and remounted to the gas spring arm. The door is operating as expected. This is an isolated incident and there are no trends for this failure mode. No further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00014 |
| MDR Report Key | 3702326 |
| Report Source | 05 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-21 |
| Date of Event | 2003-11-21 |
| Date Mfgr Received | 2013-11-21 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-04-18 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON SYSTEMS |
| 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 MAX INSTRUMENT |
| Product Code | OOI |
| Date Received | 2013-12-19 |
| Returned To Mfg | 2013-12-16 |
| Catalog Number | 441916 |
| 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 SYS |
| Manufacturer Address | SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-19 |