MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-07-26 for TRILLIUM BIO-PROBE, ADULT DP-38T 1160270-545 manufactured by Medtronic Perfusion Systems.
[678604]
Medtronic received information that this flow probe exhibited a leak, and that flows through the probe would not measure above 1l/min. This observation was made 1 minute after bypass and had been initiated. The decision was made to take the patient off bypass, and the probe was changed out. A total of 10-15cc of blood loss was suspected. There were no reported adverse patient effects associated with the changeout. It was reported that the patient expired 12 days after this procedure due to renal failure. The performance of this product is not suspected to have caused or contributed to the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[7905015]
Evaluation: device history reviewed. Results: device history review found the product met specifications when released for distribution. Conclusion: cause of event cannot be determined. Analysis: visual inspection shows some dried body fluid on the outside surface of probe near tubing connect / port interface. Further inspection under magnification shows body fluid appears to have passed through one of the parting lines past first and second barb and out to atmosphere. Probe was pressure tested to 20 psi of compressed air, however, no leak was noted. It appears the body fluid dried between tubing and port, sealing off the leak path. Tubing was removed with ease and did not appear to be adequately solvent bonded according to specifications. Flow testing identified no signs of intermittent or inaccurate readings. Conclusion: reduced performance of the device occurred and is related to the event. Review of complaints has noted no similar complaints, indicating this to be an isolated occurrence. Device changed out with no reported adverse patient effects. Medtronic will continue to monitor field performance to detect similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00085 |
| MDR Report Key | 887464 |
| Report Source | 05,07 |
| Date Received | 2007-07-26 |
| Date of Report | 2007-06-28 |
| Date of Event | 2007-06-21 |
| Date Facility Aware | 2007-06-21 |
| Report Date | 2007-06-28 |
| Date Reported to Mfgr | 2007-06-28 |
| Date Mfgr Received | 2007-06-28 |
| Device Manufacturer Date | 2007-01-27 |
| Date Added to Maude | 2008-02-04 |
| 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 | CHAD HEDLUND |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919558 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| 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 | TRILLIUM BIO-PROBE, ADULT |
| Product Code | DPT |
| Date Received | 2007-07-26 |
| Returned To Mfg | 2007-07-02 |
| Model Number | DP-38T |
| Catalog Number | 1160270-545 |
| Lot Number | 6540091 |
| ID Number | NA |
| Device Expiration Date | 2009-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 958532 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DRIVE BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-26 |