FDA Adverse Event
Death
Summary report: N
PCS2 PLASMA COLLECTION SYSTEM
MDR report key: 12020289
·
Received June 17, 2021
Report
- Report Number
- 1219343-2021-00037
- Event Type
- Death
- Date Received
- June 17, 2021
- Date of Event
- April 26, 2021
- Report Date
- May 18, 2021
- Manufacturer
- HAEMONETICS CORPORATION
- Product Code
- GKT
- UDI-DI
- 30812747011819
- PMA / PMN Number
- BK150292
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE PCS®2 PLASMA COLLECTION SYSTEM. HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE UNIT AND THE UNIT WAS OPERATING WITHIN SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.
Description of Event or Problem · 1
ON MAY 18, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE WERE NO ERRORS OBSERVED DURING DONATION. THE CAUSE OF DEATH IS UNKNOWN AND IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915920 | PCS2 PLASMA COLLECTION SYSTEM | PCS2,LIST NO,LN06002-110-NA-EW | GKT | HAEMONETICS CORPORATION | 06002-110-NA-EW | 30812747011819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Death |