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 2020-03-04 for CS ELITE PROCESSING KIT, 70ML manufactured by Haemonetics Corporation.
[182411399]
The blood volume lost was 140ml with no consequence to the patient and allogenic red cells pellet were transfused back. Instigation of the unit is still on-going.
Patient Sequence No: 1, Text Type: N, H10
[182411400]
On (b)(6) 2020, a customer informed haemonetics of adverse event that occurred during a surgery for congenital cardiopathy. The customer reported that there was an audible noise during the procedure and procedure was stopped immediately. In addition, plastic dust was found on the bowl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00010 |
| MDR Report Key | 9787998 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-04 |
| 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 | CS ELITE PROCESSING KIT, 70ML |
| Generic Name | CS ELITE PROCESSING KIT, 70ML |
| Product Code | CAC |
| Date Received | 2020-03-04 |
| Model Number | CS ELITE PROCESSING KIT, 70ML |
| Lot Number | 0919014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2020-03-04 |