MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP CARDIAC SUCTION TUBE; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	10052
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: DLP CARDIAC SUCTION TUBE
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 7613155
• Report Number: 2184009-2018-00015
• Device Sequence Number: 19382021
• Product Code: DTS
• UDI-Device Identifier: 20613994698319
• UDI-Public: 20613994698319
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K791846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 10052
• Device Catalogue Number: 10052
• Device Lot Number: 2017091193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1