MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-05-23 for SILICONE MEMBRANE OXYGENATOR I-4500-2A 61399402655 manufactured by Medtronic Perfusion Systems.
[613507]
Medtronic received information that this silicone exhibited a leak at the temperature port after 8 hours of use. The leak resulted in blood loss of approximately 5cc. The product had been primed for 30 minutes prior to use. The decision was made to change out of the device, which was performed without reported complication. The product will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[7954863]
Eval method: no information available. Results: device history review could not be performed as no product specific information is available. Analysis: although requested, this product will not be returned for analysis. Because the product is not returning, we are unable to determine a root cause for the report. In addition, product identification information, including serial and lot numbers, was not provided. Consequently, the device history record could not be reviewed. Conclusion: the exact cause for this event could not be determined as the product was discarded. The complaint has been logged for trending purposes. Medtronic continues to monitor field performance to detect similar events. Product changed out with no reported adverse patient effects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00066 |
| MDR Report Key | 855967 |
| Report Source | 01,05,07 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-04-23 |
| Date of Event | 2007-02-13 |
| Date Facility Aware | 2007-02-13 |
| Report Date | 2007-04-23 |
| Date Reported to Mfgr | 2007-04-23 |
| Date Mfgr Received | 2007-04-23 |
| Date Added to Maude | 2007-06-13 |
| 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 | UNKNOWN |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHAD HEDLUND |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919558 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE MEMBRANE OXYGENATOR |
| Product Code | BYS |
| Date Received | 2007-05-23 |
| Model Number | I-4500-2A |
| Catalog Number | 61399402655 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 846156 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-23 |