MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-19 for DLP CARDIAC SUCTION TUBE 10052 manufactured by Perfusion Systems.
[111443258]
Product analysis: visual analysis of the returned cannula shows that the tip has separated from the device. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[111443259]
Medtronic received information that during use while doing the routine count check, the scrub nurse discovered the soft tip of the cannula had dropped off. It was found within the patient's chest wall. The product was replaced. There was no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[119222630]
Investigation: the complaint was confirmed for the tip coming off. It is unknown what may have caused this occurrence. The device history record was reviewed, the review found four individuals in training on the lot, with two performing the tip bonding process. The product passed all required inspection checks, with no non-conformances noted. There were no adverse patient effects as a result of this incidence. Medtronic will continue to monitor for similar future events. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2018-00015 |
| MDR Report Key | 7613155 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-19 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-06-19 |
| 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 | 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 | 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 | DLP CARDIAC SUCTION TUBE |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2018-06-19 |
| Returned To Mfg | 2018-06-08 |
| Model Number | 10052 |
| Catalog Number | 10052 |
| Lot Number | 2017091193 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-06-19 |