MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-19 for COULTER LH700 SERIES PAK N/A 8547195 manufactured by Beckman Coulter, Inc..
[16105018]
A customer contacted beckman coulter inc. (bec) reporting that a box of the lh700 series pak (lot # 110885k) was received leaking. The customer stated the foil seal was not completely sealed and only a few milliliters of the erythrolyse leaked. The user was wearing personal protective equipment (ppe) consisting of gown, gloves and goggles at the time of the incident. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. There was no death, injury or change to patient treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[16335776]
The lh700 series pak was replaced. The root cause of the leak is that per the customer the foil seal was not completely sealed. Service was not dispatched for this event. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01245 |
| MDR Report Key | 2216934 |
| Report Source | 05,06 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-07-19 |
| Date of Event | 2011-07-19 |
| Date Mfgr Received | 2011-07-19 |
| Device Manufacturer Date | 2011-06-06 |
| Date Added to Maude | 2012-06-21 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | COULTER LH700 SERIES PAK |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-08-19 |
| Model Number | N/A |
| Catalog Number | 8547195 |
| Lot Number | 110885K |
| ID Number | N/A |
| Device Expiration Date | 2012-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-19 |