MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-02-15 for SILICONE MEMBRANE OXYGENATOR I-4500-2A 61399402655 manufactured by Medtronic Perfusion Systems.
[557734]
Medtronic received information that the i-4500 -2a oxygenator leaked during priming. Fluid was observed coming from the gas outlet port of the unit. The unit was changed out and not used for patient care.
Patient Sequence No: 1, Text Type: D, B5
[7820268]
Analysis: a visual inspection of the returned product shows no signs of damage to the outer wrap of the device. The unit was tested following the manufacturing test specifications, and no leaks were observed from the unit during the 70 minute test. Following this test, the oxygenator was again tested-this time with flows at 6. 5 l/min and 10 psi back pressure for 30 minutes. Again, no leakage was detected from the gas port or from the end cap area. However, dissection of the unit did show moisture inside the membrane envelope, near the end roll. After drying overnight, a vacuum test was performed, showing a very slight leak in the silicone membrane. Microscope inspection shows a small abrasion cut in the membrane approximately. 020" long. Conclusion: our analysis of the returned product shows that a small abrasion-type cut in the membrane is the cause of the leakage. We will continue to monitor field performance to detect similar events, should they occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00024 |
| MDR Report Key | 837369 |
| Report Source | 05,07 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-01-23 |
| Report Date | 2007-01-23 |
| Date Reported to Mfgr | 2007-01-23 |
| Date Mfgr Received | 2007-01-23 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-04-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURALIE MILLIKAN |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919124 |
| 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 |
| Generic Name | BYS |
| Product Code | BYS |
| Date Received | 2007-02-15 |
| Returned To Mfg | 2007-01-30 |
| Model Number | I-4500-2A |
| Catalog Number | 61399402655 |
| Lot Number | 4388858 |
| ID Number | NA |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 824678 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-15 |