MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for CELL SAVER? 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM 02005-220-EP manufactured by Haemonetics Corporation.
[185674041]
Another machine was brought in to complete the procedure with no issues however there was a delay in blood reinfusion. A field service engineer was dispatched but due to the lockdown in france because of the covid-19 virus the unit will be inspected at a later date.
Patient Sequence No: 1, Text Type: N, H10
[185674042]
On (b)(6) 2020, haemonetics was informed by the customer of a device malfunction resulting in the machine shutting off 3 times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00028 |
| MDR Report Key | 9889879 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2008-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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? 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM |
| Generic Name | CS5+,220V ENG,LN02005-220-EP |
| Product Code | CAC |
| Date Received | 2020-03-27 |
| Model Number | 02005-220-EP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-27 |