MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-20 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2607145]
A customer contacted beckman coulter inc. , (bec) and reported that approximately 5ml of clear liquid was leaking under the lh 780 analytical station. Although the leak was observed from the lh780 instrument by the customer, the actually the leak was caused by tubing connected to the coulter lh 750 slidemaker. The leak was not contained within the instrument. The customer was wearing personal protective equipment (ppe) consisting of a lab coat and gloves at the time of this event. There was no exposure to skin, mucous membranes or open wounds and medical attention was not sought. The material safety data sheet (msds) was not reviewed by the customer. There is an exposure control/risk management plan in place at the facility. There was no impact to patient results. No death or injury is attributed to this event and there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9957726]
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. A bec field service engineer (fse) was dispatched on (b)(4) 2012. The fse found the leak coming from the tubing through valve (vl114) on the slidemaker interface module. The fse resolved the leak by changing the tubing which had a hole caused by fatigue due to wear and tear. The cause of the leak was a hole worn in pinch tubing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01381 |
| MDR Report Key | 2544010 |
| Report Source | 05,06 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-09-13 |
| 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. 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 CULTER 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 | COULTER? LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-20 |
| Catalog Number | 6605633 |
| Lot Number | N/A |
| ID Number | SW VERSION 1B1 |
| 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 | 2012-04-20 |