MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-09-14 for LH SLIDE STAINER 6605645 manufactured by Beckman Coulter Inc..
[2174915]
The customer indicated that they had observed a leak on a lh slide stainer on two different days. This is report one of two and represents the lh slide stainer leak observed on (b)(6) 2011 initially, the customer had indicated that the leak had not caused an overflow of the lh slide stainer overflow trays. However, a beckman coulter inc. Field service engineer while on site to address the lh slide stainer leak, indicated that the customer had reported that the lh slide stainer bath number two had leaked and had overflowed the instrument trays. The healthcare workers interfacing with the machine were wearing personal protective equipment, which included laboratory coats and gloves, at the time of occurrence there was no biohazardous exposure to healthcare worker uncovered wounds or mucous membranes and no injuries were reported. No personnel sought any medical attention in association with this event. No patient results were affected by this event. No death, injury or modification to patient treatment was associated with this event. There was an exposure plan in place at the facility and a material safety data sheet was available.
Patient Sequence No: 1, Text Type: D, B5
[9390653]
Service was dispatched to the site on (b)(4) 2011 for this event. The field service engineer (fse) replaced the fill and drain tubing to bath two and replaced the waste filter. The instrument was returned into service after completion of verified repairs. The root cause of the leaks were ultimately attributed to a damaged sensor mechanism and a plug in the stain fill tube. Mdrs associated with this event: 1061932-2011-01445, 1061932-2011-01444.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01444 |
| MDR Report Key | 2247439 |
| Report Source | 05,06,07 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-08-12 |
| Date Mfgr Received | 2011-08-12 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| 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 | LH SLIDE STAINER |
| Generic Name | SLIDE STAINER, AUTOMATED |
| Product Code | GHK |
| Date Received | 2011-09-14 |
| Model Number | NA |
| Catalog Number | 6605645 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-14 |