MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2014-02-18 for DLP CARDIAC SUCTION TUBE 10052 manufactured by Perfusion Systems.
[3991584]
Medtronic received information suggesting that during the use of this cannula, the blue soft tip end of the cannula detached from the cannula and was loose in the patient. The tip was found in the patient's heart. No further information was provided regarding the event or the patient's condition. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[4418891]
Medtronic received information suggesting that during the use of this dlp suction tube, the blue soft tip end of the tube detached from the tube and became lost in the patient. The tip was found in the patient's heart.
Patient Sequence No: 1, Text Type: D, B5
[11652523]
Medtronic received information that at least two months had elapsed between the date of the product event and the date the user facility made medtronic aware of the product event. Medtronic was informed that during this time the individuals involved with this product event became unaffiliated with the facility. The facility was unable to provide additional details regarding the patient or product event. A follow-up report will be submitted if additional information is received. Analysis: medtronic has not received the product associated with this product event. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. Should the product be returned, a follow up report will be submitted. Conclusion: following the product event investigation a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[11793392]
Medtronic quality engineers could not determine a cause for the product event because the device was not available for return to medtronic. The device history record was reviewed. No abnormalities were documented during the manufacture of this product and all inspections passed. If any further information is provided or if the product is returned to medtronic the event will be re-evaluated and a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[11853953]
Correction was made to the event description to show that the product involved was a suction tube rather than a cannula product. No other changes were made.
Patient Sequence No: 1, Text Type: N, H10
[101848559]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2014-00009 |
| MDR Report Key | 3632922 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2014-02-18 |
| Date of Report | 2014-01-21 |
| Date Mfgr Received | 2014-01-21 |
| Device Manufacturer Date | 2013-09-03 |
| Date Added to Maude | 2014-02-18 |
| 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 | MIKE GAFFNEY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635265629 |
| Manufacturer G1 | MEDTRONIC STRUCTURAL HEART |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DLP CARDIAC SUCTION TUBE |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2014-02-18 |
| Model Number | 10052 |
| Catalog Number | 10052 |
| Lot Number | 2013081725 |
| Device Expiration Date | 2016-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-18 |