MAUDE Adverse Event Report: SORIN GROUP USA, INC. TBG PVC 1/4X1/16 12 FT 5; CUSTOM PERFUSION PACK

Catalog Number SL5050

Device Problem Tube(s), splitting of (1653)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  Other  

Event Description

Sorin group received a report that the tubing in the suction pump split during a procedure.There was no report of patient injury.

Manufacturer Narrative

The patient identifier was not provided.Sorin group received a report that the tubing in the suction pump split during a procedure.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the tubing in the suction pump split during a procedure.There was no report of patient injury.None of the tubing was returned to sorin group usa for evaluation.Evaluation of representative tubing from inventory, including a tubing life test, was unable to reproduce the type of failure seen in the returned tubing and found no evidence to suggest a product defect.All samples lasted well beyond the rated lifetime of 6 hours.A review of the dhr was unable to identify any concessions, deviations or non-conformities relevant to the reported failure.The customer stated that the pump head may have been over-occluded during use.The sorin heart-lung instructions for use states "failure to maintain proper occlusion of the roller pump can lead to premature pump head tubing failure." it has been concluded that the reported issue was caused by over-occlusion of the roller pump.No trend for this type of issue has been identified therefore no corrective actions are planned at this time.

• Brand Name: TBG PVC 1/4X1/16 12 FT 5
• Type of Device: CUSTOM PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4388037
• MDR Text Key: 18033813
• Report Number: 1718850-2014-00495
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 02/29/2016
• Device Catalogue Number: SL5050
• Device Lot Number: 1303600006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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
• Patient Age: 62 YR
• Patient Weight: 103