MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-07-28 for DLP PERICARDIAL/INTRACARDIAC SUMPS 12112 manufactured by Perfusion Systems.
[4611564]
Medtronic received information that during use in a procedure, the suction portion of this intracardiac sump came off from the device and was resting in the patient's chest. The section was retrieved and the product was replaced. There were no adverse patient effects as a result of the disconnection or recovery of the piece.
Patient Sequence No: 1, Text Type: D, B5
[12096043]
Upon receipt at medtronic's quality assurance laboratory, visual analysis confirmed the disconnection. There appeared to be damage to the tubing and sump at the interface where the disconnection occurred. After cleaning, further visual examination under magnification confirmed the presence of adhesive residue on the connection. The product has been sent to the contract manufacturer of this device for further examination. Upon completion of the investigation by medtronic's quality engineers and the contract manufacturer, a supplemental report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2014-00057 |
| MDR Report Key | 3959411 |
| Report Source | 05,06,07 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2013-04-23 |
| Date Added to Maude | 2014-07-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| 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 PERICARDIAL/INTRACARDIAC SUMPS |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2014-07-28 |
| Returned To Mfg | 2014-07-14 |
| Model Number | 12112 |
| Catalog Number | 12112 |
| Lot Number | 2013041096 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-07-28 |