MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-25 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter Inc..
[2644656]
A customer contacted beckman coulter inc (bec) stating that there was a blood and diluent leak at the dispense probe of their coulter lh 750 slidemaker which was contained within the unit. The customer was unable to determine the source of the leak. There is an exposure control plan in place at the facility. The operators were wearing gloves at the time of the incident. No injury or exposure was reported. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[9928877]
A field service engineer (fse) went on-site the day of the event and inspected the instrument, but could not reproduce leak. Fse removed slide that was against probe and could have potentially led to a leak. Fse observed vacuum sensor error and replaced sensor, shuttle tubing, filter and choke. Fse then ran shutdown and startup which passed and no leak was observed. Fse also ran numerous slides with no leaks. The cause of the leak could not be confirmed. Fse clarified the following day that the slide was against the probe because the instrument was experiencing vacuum problems leading the slide to fall off. Per fse, it is possible that the probe did not reach completely into the rinse block due to the slide being in its way, thus causing a leak. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01677 |
| MDR Report Key | 2589368 |
| Report Source | 05,06 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-04-30 |
| Date of Event | 2012-04-30 |
| Date Mfgr Received | 2012-04-30 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2012-10-01 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH 750 SLIDEMAKER |
| Generic Name | AUTOMATED SLIDE SPINNER |
| Product Code | GKJ |
| Date Received | 2012-05-25 |
| 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 INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-25 |