MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for IMPELLA 2.5 manufactured by Abiomed, Inc.
[38981215]
Patient Sequence No: 1, Text Type: N, H10
[38981216]
The patient who had been transferred from another facility following an acute chest pain episode. On arrival troponin levels were 5. 83 and 6. 89; diagnosed with non-st-segment elevation myocardial infarction (nstemi). Patient became acutely hypotensive with worsening altered mental status and required an emergent cardiac catheter with an impella device placement. Patient was critically ill and after two days of medical management, family decided to allow nature death for patient and not pursue any further treatment. Impella device was to be removed two days later. During that process, nurse had pushed power off button and indicated to physician that they could remove device. As the impella catheter was being removed blood began to spray out, which no one expected. It was later discovered that the nurse had not pushed "enter" after putting the power level to power off. Preliminary assessment was that the device did not malfunction; it was use error because nurse had not finished sequence when powering off device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5459889 |
| MDR Report Key | 5459889 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-11 |
| Report Date | 2016-02-19 |
| Date Reported to FDA | 2016-02-19 |
| Date Reported to Mfgr | 2016-02-19 |
| Date Added to Maude | 2016-02-25 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | IMPELLA 2.5 |
| Generic Name | TEMPORARY CARDIAC SUPPORT PUMP |
| Product Code | PBL |
| Date Received | 2016-02-25 |
| Returned To Mfg | 2016-01-11 |
| ID Number | 92903 |
| Device Expiration Date | 2017-08-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-25 |