MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-20 for COOL FLOW IRRIGATION PUMP M-5491-02 CFP002 manufactured by Hei, Inc.
[22051015]
The investigation of this complaint is still in progress. This report will be updated upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22121042]
It was reported that, during an afib ablation on the left atrium, the left pulmonary veins had almost been isolated and the physician was ablating in the septal posterior wall, when it was noticed that the patient's systolic blood pressure dropped to 40. An alleged pericardial effusion was noted with the sequoia intracardiac imaging. A catheter was placed in the pericardium through the patient's anterior chest wall to withdraw the red colored fluid. The physician terminated the procedure, and the patient was stabilized, and remained in the hospital. This procedure was performed under general anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721752-2009-00003 |
| MDR Report Key | 1320966 |
| Report Source | 06 |
| Date Received | 2009-02-20 |
| Date of Report | 2009-01-23 |
| Date of Event | 2009-01-23 |
| Date Mfgr Received | 2009-01-23 |
| Date Added to Maude | 2009-02-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | DIANA THORSON |
| Manufacturer Street | 15715 ARROW HWY |
| Manufacturer City | IRWINDALE CA 91706 |
| Manufacturer Country | US |
| Manufacturer Postal | 91706 |
| Manufacturer Phone | 9098398604 |
| Manufacturer G1 | HEI INC |
| Manufacturer Street | 4801 NORTH 63RD. ST. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL FLOW IRRIGATION PUMP |
| Generic Name | DRF PUMP, CIRCULATING-FLUID, LOCALIZED HEAT |
| Product Code | KQT |
| Date Received | 2009-02-20 |
| Model Number | M-5491-02 |
| Catalog Number | CFP002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEI, INC |
| Manufacturer Address | BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2009-02-20 |