MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-29 for LN CSE-E-US MACHINE manufactured by Haemonetics Corporation.
[176858750]
Preliminary autopsy found microthrombi consistent with endometrial material in all lobes of both lungs. A field service engineer inspected and performed all functional test and confirmed that all functions passed. The unit is operating within manufacturing standards.
Patient Sequence No: 1, Text Type: N, H10
[176858751]
On january 2, 2020, haemonetics was informed of a patient fatality via a medwatch 3500a (003902226-2019-0001) sent in the mail. Surgery progressed normally. Est. Blood loss 300ml. At conclusion when closing skin and returning blood to patient the patient went into cardiac arrest. Patient expired despite resuscitation efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00004 |
| MDR Report Key | 9643651 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2015-09-17 |
| Date Added to Maude | 2020-01-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SHAUN FLANAGAN |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal | 02110 |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LN CSE-E-US MACHINE |
| Generic Name | CELL SAVER ELITE |
| Product Code | CAC |
| Date Received | 2020-01-29 |
| Model Number | CSE-E-US |
| Lot Number | 15H569SPG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION |
| Manufacturer Address | 125 SUMMER STREET BOSTON MA 02110 US 02110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-29 |