MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for HORIZON CENTRIFUGE 642 E manufactured by Unk.
[132374981]
The blood tube was inserted into the centrifuge and after starting the centrifuge, the machine made a clanking noise and then we heard something burst and saw blood inside the machine. We were unable to clean the machine due to the probability of exposing ourselves to blood-borne pathogens since there is an excess amount of blood and also sharp fragments in the machine. We have returned the machine back to labcorp for them to decide how to take care of it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082827 |
| MDR Report Key | 8214034 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-31 |
| Date Added to Maude | 2019-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HORIZON CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2019-01-02 |
| Model Number | 642 E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-02 |