MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for TANDEMHEART PUMP 5120-0000 manufactured by Cardiacassist Inc..
[188700470]
It was reported that within minutes of beginning support the perfusionist reported that the flow dropped from 4l to 2l and eventually 0l while the patient was on the or table. The pump and oxygenator were exchanged. Device history records were reviewed for the returned pump and oxygenator. Both were reviewed and no conformities or abnormalities were found. The pump and oxygenator were received by the manufacturer for product analysis. When the pump was returned a thrombus was evident on the impeller vanes and the current draw values were higher than specified, potentially due to the thrombus observed. It cannot be determined whether the thrombus was present during use in the field, or whether it was a result of return shipping conditions. During internal visual inspection of the pump lower housing and journal bores, particulate was found which may indicate improper priming of the pump during use. The drop in flow was likely due to an increased resistance of the oxygenator due to thrombus formation. No further relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531527-2020-00014 |
| MDR Report Key | 9820087 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-03-11 |
| 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 | MRS. NJEMILE CRAWLEY |
| Manufacturer Street | 620 ALPHA STREET |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer Phone | 2812287200 |
| 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 | 2020-03-11 |
| Model Number | 5120-0000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-11 |