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

Model Number 10052

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

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 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.

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
• Type of Device: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7613155
• MDR Text Key: 111443258
• Report Number: 2184009-2018-00015
• Device Sequence Number: 1
• Product Code: DTS
• UDI-Device Identifier: 20613994698319
• UDI-Public: 20613994698319
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K791846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1