MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for TANDEMHEART PUMP 5120-0000 manufactured by Cardiacassist Inc..
[188007038]
Patient information was not provided. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Cardiacassist inc. Manufactures the tandemheart pump. The incident occurred in (b)(6). Investigation is in progress. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[188007039]
Cardiacassist received a report about a sudden stop of the tandemheart pump displaying an error message "low flow" during procedure and it required replacement of the device. The patient desatted to the 20%. After pump replaced saturation went back to the 80% where they were previously. The patient required increased vent support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531527-2020-00015 |
| MDR Report Key | 9878018 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ENRICO GRECO |
| Manufacturer Street | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer G1 | CARDIACASSIST INC. |
| Manufacturer Street | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANDEMHEART PUMP |
| Generic Name | NON-ROLLER TYPE BLOOD PUMP |
| Product Code | KFM |
| Date Received | 2020-03-25 |
| Model Number | 5120-0000 |
| Catalog Number | 5120-0000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIACASSIST INC. |
| Manufacturer Address | 620 ALPHA DRIVE PITTSBURGH PA 15238 US 15238 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |