MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-27 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter.
[3131134]
A customer contacted beckman coulter (bec) to report a leak of 3ml of bloody fluid that was discovered in a coulter lh 750 slidemaker while troubleshooting a printer error on the right side near the dispense probe. The leak was contained within the instrument. The operator was wearing personal protective equipment (ppe) consisting of a lab coat, gloves and face shield at the time of the event. No injury or exposure was reported. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[10580178]
A field service engineer (fse) went on-site and indicated that excessive blood splatter was identified on the instrument which confirmed the leak. Fse reported that the blood sample waste was unable to drain correctly due to inadequate vacuum during draining. Fse cleaned the rinse block and checked ports for partial plugs. Fse also backwashed the vacuum lines with distilled water and drained the vacuum accumulator chamber (vacuum chamber vc11) to stabilize the vacuum applied during draining. Instrument performance was verified and no further leaks were observed. The customer was contacted by bec on (b)(4) 2013 about the printer errors mentioned. Per customer, they had resolved the issues related to the printer. Information on these errors was requested but not provided. The cause of the leak is attributed to the vacuum chamber vc11. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00239 |
| MDR Report Key | 2981690 |
| Report Source | 05,06 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-31 |
| Date of Event | 2013-01-31 |
| Date Mfgr Received | 2013-01-31 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2013-05-06 |
| 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 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH 750 SLIDEMAKER |
| Generic Name | AUTOMATED SLIDE SPINNER |
| Product Code | GKJ |
| Date Received | 2013-02-27 |
| Model Number | LH 750 SLIDEMAKER |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-27 |