MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-21 for MIKRO 120 1204 (CENTRIFUGE) manufactured by A. Hettich Gmbh & Co. Kg.
[18180805]
The event happened with a microliter centrifuge. During the run the screw holding the rotor came loose. The screw then destroyed the closure of the centrifuge lid left the centrifuge and hit the wall. No one was hurt.
Patient Sequence No: 1, Text Type: D, B5
[18204105]
Rotor not correctly fastened to motor shaft. Whether the user didn't fasten the screw correctly or whether the screw came loose in spite of correct fastening cannot be reconstructed. After coming off the rotor the screw damaged the plastic lid latch of the centrifuge lid. Thus the lid opened and the screw was thrown out of the centrifuge. Centrifuges of that type are not produced anymore. They have been replaced by an improved version. With this improved version all corrective actions have been implemented. Actually there is a recall action taking place. With the help of exchange sets which converts these centrifuges into improved versions poorly designed versions still present in the field will be eliminated. For reasons not known by us this centrifuge was not yet subject to our recall action. Similar case already reported to fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990076-2011-00009 |
| MDR Report Key | 2481677 |
| Report Source | 07 |
| Date Received | 2011-06-21 |
| Date of Report | 2011-06-21 |
| Date of Event | 2011-05-03 |
| Date Facility Aware | 2011-05-05 |
| Report Date | 2011-06-21 |
| Date Reported to FDA | 2011-06-21 |
| Date Reported to Mfgr | 2011-05-05 |
| Date Mfgr Received | 2011-05-05 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2012-06-11 |
| 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 | 0 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | FOEHRENSTRASSE 12 |
| Manufacturer City | TUTTLINGEN D-78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-78532 |
| Manufacturer Phone | 461705162 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIKRO 120 |
| Generic Name | CENTRIFUGE MICROSEDIMENTATION |
| Product Code | GHK |
| Date Received | 2011-06-21 |
| Returned To Mfg | 2011-05-06 |
| Model Number | 1204 (CENTRIFUGE) |
| ID Number | 1224 (ROTOR) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A. HETTICH GMBH & CO. KG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-21 |