MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for HEARTWARE manufactured by Heartware.
[68170906]
On (b)(6) 2017, pt reports having high power alarms around 6 w that began at 0300. These alarms continued so he was instructed to come to (b)(6). A stat echo was performed that concluded a thrombus in the inlet cannula. Pt was transferred to the icu for closer monitoring. He underwent a hvad pump exchange on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6349336 |
| MDR Report Key | 6349336 |
| Date Received | 2017-02-17 |
| Date of Report | 2016-02-16 |
| Date of Event | 2017-02-10 |
| Date Facility Aware | 2017-02-10 |
| Report Date | 2017-02-16 |
| Date Reported to FDA | 2017-02-16 |
| Date Added to Maude | 2017-02-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEARTWARE |
| Generic Name | HVAD |
| Product Code | OKR |
| Date Received | 2017-02-17 |
| Returned To Mfg | 2017-02-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2017-02-17 |