MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-02 for PREVI? COLOR V2 414292R manufactured by Biomerieux, Sa.
[122312769]
A customer from the united states notified biom? Rieux of operator/user injury in association with the previ? Color v2 instrument (ref 414292r). The customer reported the following: on (b)(6) 2018, a lab technician had completed instrument maintenance and noticed the absorbent pad under instrument was wet. Another technician lifted the front of the instrument to remove the pad and heard a crack. A large spark came out and hit the technician, and the pad burst into flames. At that point the technician pulled the plug on the instrument, pulled the fire alarm and left the room. Maintenance came in and put the fire out and waited for the fire department to arrive. The fire department determined the fire was out. The customer reported that two technicians went to the emergency room with injuries: the technician that was hit by the spark had a burn on the palm of the left hand. The er treated the wound with ointment. One technician had redness on the arm and elevated blood pressure, she was observed for about an hour with no further treatment. Both technicians were released. To be noted, methanol is approved for use with this system; however, the user manual states to always operate the instrument under a safety hood when in use. Customer confirmed they do use methanol with this instrument, but that they do not have this instrument under a safety hood. The instrument was sent in for further evaluation. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[133967360]
An investigation was performed for a customer from the united states that reported operator/user injury in association with the previ? Color v2 instrument (ref 414292r). The investigation was performed by the supplier. The most probable root cause(s): methanol leak inside the instrument that could come from the connection between the internal tubing and the tubes which plunged into the reagent bottle. Then methanol drained onto the mat under the instrument and evaporated itself around and inside the instrument. The power supply board was shorted by fluid dripping or splashing onto the components probably by a small drop of iodine which led to a spark. Combination of the methanol vapours and the spark made ignition of fire which spread up to the methanol's wet mat under the instrument. In addition: customer was using methanol without hood, which is not compliant with user manual (514726-1 en 1-2013-12-en-414292) previ color v2 cytocentrifuge rotor page 9/93 - chapter 1-2). Customer continued to use the instrument even if a leak was observed, which is not compliant with user manual (514726-1 en 1-2013-12-en-414292) previ color v2 cytocentrifuge rotor page 9/93 - chapter 1-2). Elitech proposed that action be taken to protect the power supply from any drops of reagent that may occur within its surrounding.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2018-00190 |
| MDR Report Key | 7925518 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-02 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-09-02 |
| Date Added to Maude | 2018-10-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME, LES GROTTES ISERE 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVI? COLOR V2 |
| Generic Name | PREVI? COLOR V2 |
| Product Code | KPA |
| Date Received | 2018-10-02 |
| Returned To Mfg | 2018-09-24 |
| Model Number | 414292R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME, LES GROTTES ISERE 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-02 |