MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-04-11 for UNICEL? DXH? SLIDEMAKER STAINER COULTER? CELLULAR ANALYSIS SYSTEM A82669 manufactured by Beckman Coulter.
[3361577]
An internal beckman coulter service personnel reported having thermal contact with the smear heater while servicing the engineering prototype of a unicel dxh slidemaker stainer coulter cellular analysis system during the development phase of the product. The service personnel stated that there is no indication if the smear heater is still hot after being turned off and the temperature for the heater can reach 232 degrees celsius (449. 6 degrees fahrenheit). No injury occurred and no medical attention was sought in connection with this event. In addition, there have been no reported incidents regarding this issue in the released product with similar smear heaters since product launch in november 2011. There are two smear heaters (cylinder rods) on the instrument: one for each basket elevator on the slidemaker module. The heaters dry the slides prior to staining and each smear heater contains a shield which acts as a barrier to protect the operator from the smear heater rods. The shields are designed to allow the air flow to pass through the instrument without obstruction. The smear heater area is not indicated as an area for customer access in the instrument's instruction for use (ifu) and cannot be easily accessed by a customer as it requires a tool to remove the right side instrument cover. The smear heater area may also be accessed from the front of the instrument by disengaging the interlock on the front panel. There are general precautions listed for the instrument; however, no safety precaution or warning label is currently displayed in the smear heater area or in the instrument's ifu to alert the operator of the heater's high temperature or potential burn hazard. An audit was performed on the system risk documentation and it was discovered that the counter-measure for this potential burn hazard had not been implemented prior to product release. As of (b)(4) 2013, a "hot part" danger label was not implemented for the smear heater. Failure mode is attributed to labeling deficiency.
Patient Sequence No: 1, Text Type: D, B5
[10659682]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15951847]
The unicel dxh slidemaker stainer coulter cellular analysis system referenced in the initial report was an unprotected engineering prototype utilized during the development phase of the product. The unprotected prototype had the shields around the smear heater removed for servicing by one of the internal beckman coulter engineers. The commercialized released systems are only sold with shields in place that are not removable by the customer. These shields act as a barrier to protect the operator from the smear heater elements (rods) and the shield's temperature during normal operation is at 50 to 52? C. In addition, a "hot part" surface warning label will be added to the shields as a secondary safety measure. While there was heater exposure in the prototype configuration, there is no similar device on the market without the heater shields in place as this is not the configuration for the commercialized product. Failure mode of the event is attributed to the failure to implement caution labeling for a thermal hazard identified during development.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00606 |
| MDR Report Key | 3054047 |
| Report Source | 00,07 |
| Date Received | 2013-04-11 |
| Date of Report | 2010-10-01 |
| Date of Event | 2010-10-01 |
| Date Mfgr Received | 2013-05-16 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2013-06-17 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXH? SLIDEMAKER STAINER COULTER? CELLULAR ANALYSIS SYSTEM |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2013-04-11 |
| Model Number | NA |
| Catalog Number | A82669 |
| Lot Number | NA |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-11 |