MAUDE Adverse Event Report: SORIN GROUP USA, INC. UPMC PASSAVANT PITTSB PA 2; CUSTOMER PERFUSION PACK

Catalog Number 627289301

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 01/31/2014

Event Type  Other  

Event Description

Sorin group received a report that the tubing from a sorin group heart lung pack disconnected from the outlet port of a terumo reservoir during set-up.There was no pt involvement.

Manufacturer Narrative

The lot number was not provided, therefore the manufacture date is unk.The terumo reservoir and the tubing which had been attached to the outlet port were returned to sgu for eval.Dimensional analysis of the returned tubing found that the inner diameter of the returned tubing was well below the upper specification limit at all measurement locations, including the end which had been connected to the reservoir.The returned tubing was re-connected to the outlet port of the returned reservoir and a 5kg weight was hung from the tubing for 2 hours.The tubing remained connected securely to the port throughout the duration of the test.The eval summarized above found no evidence to suggest that the issue experienced by the customer was caused by a problem with the tubing.Although the root cause for the disconnection could not be confirmed, inspection of the returned reservoir found that the outlet port has a tapered, conical shape and with less pronounced barbs.

• Brand Name: UPMC PASSAVANT PITTSB PA 2
• Type of Device: CUSTOMER PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3684050
• MDR Text Key: 4292034
• Report Number: 1718850-2014-00086
• Device Sequence Number: 1
• Product Code: DTN
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 627289301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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