MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG 34F DRAINAGE CANNULA

Catalog Number 201-50055

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The patient was supported with an extracorporeal circulatory support pump for left ventricle support.It was reported by the distributor that while the patient was moving about, the nurse noticed that blood started to weep from the point between the end of the drainage cannula and its connector.On further inspection, it was also noticed that the blue shrink wrap seal had disappeared and the connector was almost completely detached from the drainage cannula.The nurse kept both parts together and called perfusion.The connection was then secured and the original connector was replaced with a barbed connector.There was no injury to the patient.The patient remained ongoing with the repaired drainage cannula for an unspecified period of time.The patient was on day 31 of support at the time of the event.

Manufacturer Narrative

The patient¿s weight was not provided.Approximate age of device - 31 days.The connection area of the cannula is expected to be returned for analysis.It has not yet been received.The remainder of the cannula was reportedly discarded at the user facility.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.Placeholder.

Manufacturer Narrative

The end of the drainage cannula with the connector was cut off at the hospital and was returned for investigation.It was reported that the remainder of the cannula was discarded by the hospital personnel.Additionally, a photo of a piece of the drainage cannula cut off at both ends and a photo of the separated cannula without the blue shrink seal were provided.The evaluation confirmed that the connector is no longer fitted to the cannula pvc material.The end of the cannula could be removed from the connector without effort.A review of the device history records found no deviations from manufacturing or quality assurance specifications.The reported event that the "blue shrink wrap seal had disappeared and the connector was almost completely detached from the drainage cannula" is being addressed through the corrective and preventive action process.The manufacturer is closing the mdr file on this event.

• Brand Name: THORATEC CENTRIMAG 34F DRAINAGE CANNULA
• Type of Device: CANNULA
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4975785
• MDR Text Key: 6075303
• Report Number: 2916596-2015-01456
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 201-50055
• Device Lot Number: 2014071050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR