MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP FEMORAL ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 57417

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Medtronic received information that during setup the customer observed that the barbs of the connector are incorrectly oriented.The customer was unable to connect the tubing to the cannula; the customer used another non-medtronic cannula model.The medtronic cannula was not inserted as this was identified prior to patient use.There were no adverse patient effects as a result of the event.

Manufacturer Narrative

Upon receipt at medtronic, visual inspection showed the barbs on the connector to be in the wrong orientation.Preliminary investigation suggests that the root cause is related to an insert placed in the reverse orientation during the manufacturing process.No patient information was provided because there was no patient involvement.(b)(4).

Manufacturer Narrative

Medtronic's investigation confirmed that the root cause was confirmed to be a reversed insert in the injection molding process of the cannula connector at the injection molding supplier.Corrective actions were taken to prevent future recurrence of the issue.

• Brand Name: DLP FEMORAL ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4888267
• MDR Text Key: 22054552
• Report Number: 2184009-2015-00030
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K875353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/28/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 57417
• Device Catalogue Number: 57417
• Device Lot Number: 2015016317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1914-2015
• Patient Sequence Number: 1