FDA Adverse Event
Injury
Summary report: N
CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
MDR report key: 11831914
·
Received May 17, 2021
Report
- Report Number
- 1219343-2021-00019
- Event Type
- Injury
- Date Received
- May 17, 2021
- Date of Event
- April 16, 2021
- Report Date
- April 21, 2021
- Manufacturer
- HAEMONETICS CORPORATION
- Product Code
- CAC
- UDI-DI
- 10812747016537
- PMA / PMN Number
- K120586
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INFORMED HAEMONETICS THAT THEY WOULD NOT BE ABLE TO PROVIDE FURTHER PATIENT INFORMATION.
Description of Event or Problem · 1
ON 21APR2021, HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALERT ON CYCLE 5 OF A VASCULAR PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML SYSTEM. DURING PROCEDURE 2 UNITS OF DONATED BLOOD WAS NEEDED TO PRECLUDE PERMANENT IMPAIRMENT WHERE IT WOULD NOT HAVE BEEN NEEDED IF THE ISSUE WITH THE DEVICE DID NOT OCCUR. ALTHOUGH IT WAS NOT ABLE TO BE CONFIRMED WITH THE OPERATOR THAT THERE WAS AN INNER CORE LEAK THIS ERROR HAS IN THE PAST BEEN AN INDICATOR OF A POTENTIAL ISSUE WITH THE BOWL THAT HAS BEEN REPORTED. AWAITING LOT NUMBER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730504 | CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM | CSE-P-125, PRODUCT CODE: CAC | CAC | HAEMONETICS CORPORATION | CSE-P-125 | 0820012 | 10812747016537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |