MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for CELL SAVER ELITE+, UK manufactured by Haemonetics Corporation.
[185674023]
Patient was reported to have no adverse reaction for this event; however, lost 10 liters of blood during the procedure. A loss of 3. 5 liters of blood was due to vaginal bleeding that could not be salvaged. A field service engineer was dispatched and inspected the machine and replaced a pinch valve bushing. Diagnostics checks were run and unit meets manufacturers' specifications. The disposable processing kit that was used in this event was discarded. This event occurred in the united kingdom with a product that is not registered or marketed within the us. However, haemonetics has a similar device marketed and cleared for use by the fda where the alleged malfunction can potentially occur. This report is being filed due to the reported failures that could occur on a similar device marketed and cleared for use by the fda.
Patient Sequence No: 1, Text Type: N, H10
[185674024]
On (b)(6) 2020, haemonetics was informed by the customer of an adverse event and device malfunction and adverse event that happened during a gynecological procedure. A long empty alarm was sounded and a second machine was brought in to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00020 |
| MDR Report Key | 9860216 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELL SAVER ELITE+, UK |
| Generic Name | CSE-EW-UK |
| Product Code | CAC |
| Date Received | 2020-03-20 |
| Model Number | CELL SAVER ELITE+, UK |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |