MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-02-19 for COOL FLOW IRRIGATION PUMP M-5491-02 CFP002 manufactured by Hei Inc.,.
[1029243]
It was reported that fifteen minutes after a transseptal puncture during an a-fib procedure, the anesthesiologist noted a drop in the pt's blood pressure. An intracardiac echo was used to visualize the fluid in the pericardium. A 700cc pericardiocentesis of fluid removal from the pericardial space had to be performed. The customer was not sure if the perforation occurred during the transseptal step or during ablation (this was the first ablation). The pt was stabilized and transferred to icu. The pt had fully recovered. The prognosis was excellent.
Patient Sequence No: 1, Text Type: D, B5
[8202746]
Investigation is still in progress. A supplemental report on device evaluation will be submitted once it is completed. (see scanned page).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721752-2009-00001 |
| MDR Report Key | 1321068 |
| Report Source | 07 |
| Date Received | 2009-02-19 |
| Date of Report | 2009-01-22 |
| Date of Event | 2009-01-22 |
| Date Mfgr Received | 2009-01-22 |
| 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 | GAIL HAPNER |
| Manufacturer Street | 15715 ARROW HWY |
| Manufacturer City | IRWINDALE CA 91706 |
| Manufacturer Country | US |
| Manufacturer Postal | 91706 |
| Manufacturer Phone | 9098398938 |
| 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 | PUMP, CIRCULATING-FLUID, LOCALIZED HEAT |
| Product Code | KQT |
| Date Received | 2009-02-19 |
| 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. Other; 3. Required No Informationntervention | 2009-02-19 |