MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-16 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1930585]
A customer contacted beckman coulter inc. (bci) stating that one hemogard vacutainer plastic tube cap came off while the sample was being run on the coulter lh 750 analyzer, consequently spilling blood inside the instrument. The tube was in a cassette on the rocker bed when the incident occurred. No injuries occurred and medical attention was not sought. There were no reports of exposure to mucous membranes or open wounds. No change to patient treatment attributed to or connected to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[8959498]
The customer cleaned the spill according to the defined laboratory protocol. After cleaning the customer was getting "auto stop" alarms and stripper plate errors. The customer indicated that the tube was not opened prior to running and the cassette was correctly placed on the loading dock and rocker bed in the usual manner. A field service engineer (fse) was dispatched and indicated that the stripper plate assembly was disassembled, so the fse cleaned and reassembled it. The alignment of the stripper plate with sample tube was also checked with satisfactory results. Multiple patient samples were run without any issues. The root cause could not be determined to date for this event. Per labeling, beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00082 |
| MDR Report Key | 1994170 |
| Report Source | 06 |
| Date Received | 2011-02-16 |
| Date of Report | 2011-01-19 |
| Date of Event | 2011-01-19 |
| Date Mfgr Received | 2011-01-19 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2012-02-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-02-16 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| 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 | 2011-02-16 |