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 2020-01-29 for CELL SAVER ELITE PROCESSING SET (225 ML) CSE-P-225 manufactured by Haemonetics Corporation.
[176869035]
The field service engineer went onsite to gather data on the procedure and discovered the leak occurred on cycle 4, with the total volume reinfused of 625ml during the procedure. The bowl was returned to haemonetics for evaluation. Evaluation of the returned bowl confirmed that a leak did occur in the inner core where the bowl base joins with the outer part of the inner core. This could be the possible cause of the leak at the dynamic seal however, it was not possible to confirm due to the condition of the returned sample. There is nothing at this time that would indicate that the death was related to the machine used. It was mentioned by the customer used another cell saver and a new set was used, to continue the procedure, but no further information was provided.
Patient Sequence No: 1, Text Type: N, H10
[176869036]
On 16 december 2019: haemonetics was informed by the customer of a patient death the next day after surgery. During a surgery with the cell saver elite processing set emitted an alarm for "liquid in the centrifuge". It was reported there was a loss of 250ml in the bowl and from the bowl reservoir. The leak occurred on cycle 4, with a total volume reinfused of 625ml during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00001 |
| MDR Report Key | 9644075 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2015-07-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CELL SAVER ELITE PROCESSING SET (225 ML) |
| Generic Name | CELL SAVER ELITE PROCESSING SET (225 ML) |
| Product Code | CAC |
| Date Received | 2020-01-29 |
| Model Number | CSE-P-225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 |