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 2020-03-20 for CONC PLT & PLS SET W/FILTER 999F-E manufactured by Haemonetics Corporation.
[185672146]
Donor was reported to be fine after 2 doses of calcium. When the draw was started there was already anticoagulant in the bowl. On the return air was coming from the platelet bags but the bags were without air because of the very short draw. The tubing was not set properly resulting in the misplacement of the air. This event occurred in croatia with a product that is not registered or marketed within the us. However, haemonetics has a similar device marketed and cleared for use by the fda where the alleged malfunction can potentially occur. This report is being filed due to the reported failures that could occur on a similar device marketed and cleared for use by the fda.
Patient Sequence No: 1, Text Type: N, H10
[185672147]
On (b)(6) 2020, haemonetics was informed by the customer of an adverse event. Several warnings that the pressure was too low.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00022 |
| MDR Report Key | 9862803 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | CONC PLT & PLS SET W/FILTER |
| Generic Name | 999F-E |
| Product Code | GKT |
| Date Received | 2020-03-20 |
| Model Number | 999F-E |
| Lot Number | 8919039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-03-20 |