MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-26 for BECKMAN COULTER ? COULTER ? LH 750 SLIDEMAKER LH750 SM 6605633 manufactured by Beckman Coulter, Inc..
[2693261]
The customer reported approximately 10 ml of fluid, which appeared to be a waste product, leaked from the beckman coulter coulter lh 750 slidemaker. The customer stated the leak was noted inside the slidemaker and on the table. The customer was wearing personal protective equipment (ppe) consisting of a lab coat, eye protection, and gloves. The customer did not come in contact with the fluid and did not seek medical attention. No exposure (sprayed or splashed) to mucous membranes or open wounds were reported. No death, injury or changes to patient treatment or results are associated with this event. The customer did not review the msds. The facility does have a risk management / exposure control plan is in place. On the day of the event, a field service engineer (fse) found diluent mixed with blood in the bottom tray, however, it was contained by turning the slidemaker off. The fse observed the leak coming from a hole in the tubing at vl19 and resolved the issue by replacing the black tubing. As a precaution, tubing on vl16 to vl21 was also replaced. Several slides were run with no further issues. Service activity performed is verified to meet the specified requirements per established procedures as documented in the service report and customer record. Vl19 is a probe backwash. The dispense probe of the slidemaker contains patient blood and diluent during operation and cleaning agent at shutdown.
Patient Sequence No: 1, Text Type: D, B5
[9962004]
The cause of the leak was a hole in tubing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01413 |
| MDR Report Key | 2550960 |
| Report Source | 05,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-11 |
| Date of Event | 2012-04-11 |
| Date Mfgr Received | 2012-04-11 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2012-09-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER ? COULTER ? LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-26 |
| Model Number | LH750 SM |
| Catalog Number | 6605633 |
| Lot Number | N/A |
| ID 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 | 250 S KRAEMER BLVD BREA, CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-26 |