MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-05-08 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2655839]
A customer contacted beckman coulter inc. , (bec) and reported that they observed a clear fluid leak in the tubing through valve 115 (vl115) on the coulter lh 750 slidemaker. The leak was contained within the instrument. The customer was wearing personal protective equipment (ppe) consisting of a lab coat and gloves. There was no exposure to mucous membranes or open wounds. No one sought medical attention. The material safety data sheet (msds) was not reviewed. There is a risk management/exposure control plan in place at the facility. Patient results were not affected. There were no discrepant results reported. There was no change to patient treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[9965080]
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. Bec field service engineer (fse) was dispatched on (b)(4) 2012, for this event. The fse inspected the instrument and found a pinhole leak was actually at valve 114 (vl114). The fse replaced the tubing at vl114 to resolve the leak. Service activity was verified to meet specified requirements per established procedures. Results met published performance specifications. Failure mode for this event is a pinhole leak in tubing at valve 114. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01476 |
| MDR Report Key | 2565113 |
| Report Source | 01,05,06 |
| Date Received | 2012-05-08 |
| Date of Report | 2012-04-12 |
| Date of Event | 2012-04-12 |
| Date Mfgr Received | 2012-04-12 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2012-09-19 |
| 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 | 2012-05-08 |
| Model Number | NA |
| Catalog Number | 6605633 |
| Lot Number | N/A |
| ID Number | NA |
| 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 | 2012-05-08 |