MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-17 for MEDTRONIC INTERSEPT 1351/CB manufactured by Metronic Af Business.
[236720]
Pt passed away because of a malfunction of device called intersept 1351/cb. The dr performing the heart surgery told rptr that the device did not operate properly resulting in the death. Rptr stated that device lacked a safety valve. This device is a cardiotomy reservoir used during open heart surgery.
Patient Sequence No: 1, Text Type: D, B5
[239903]
Add'l info rec'd from mfr 1/18/2002: this is in response to the letter requesting info to assist in evaluating an incident that was reported to the center on 11/17/2001. The report, #mw4003140 was created and coded by the agency after a letter was received from a private individual. No medwatch report had been received. The info provides no hosp or healthcare professional reference that allows mfr to accurately link the info to a report or to follow up with the facility to obtain further info. Mfr understands and support the need to keep the source of info confidential, but based on the info provided in letter and report, mfr is unable to positively identify the event and respond to questions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003140 |
| MDR Report Key | 364181 |
| Date Received | 2001-11-17 |
| Date of Report | 2001-11-17 |
| Date Added to Maude | 2001-12-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC INTERSEPT 1351/CB |
| Generic Name | BLOOD FILTER CARDIOTOMY SUCTION LINE |
| Product Code | JOD |
| Date Received | 2001-11-17 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 353283 |
| Manufacturer | METRONIC AF BUSINESS |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 554323568 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2001-11-17 |