MAUDE Adverse Event Report: SORIN GROUP USA, INC. VOLUNTEER PERF KNOXVILLE TN1; CUSTOM PERFUSION PACK

Catalog Number 044014100

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

Patient Problem No Patient involvement (2648)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Sorin group rec'd a report that the clinician was tapping the arterial filter to debubble the filter when the outlet port broke off during priming.There was no pt involvement.

Manufacturer Narrative

This custom perfusion pack is mfg by sorin group usa inc.The d733 micro 40 ph.I.S.O.Arterial filter is mfg by sorin group (b)(4) and is a component of this pack.Sorin group rec'd a report that the clinician was tapping the arterial filter to debubble the filter when the outlet port broke off during priming.There was no pt involvement.One d733 micro 40 arterial filter (b)(4) was returned to sgu for eval.Upon receipt the unit was subjected to visual inspection.Visual inspection confirmed the outlet port of the arterial filter had broken off.The tubing and other piece of the outlet port was not returned for eval.No significant whitening or deformation was observed in the material at the break site.No other defects or abnormalities were noted.A review of the device history record by sorin group (b)(4) found no deviations or abnormalities related to the reported issue.Mfg records were verified as confirming to specification.Although the root cause could not be confirmed, sorin group (b)(4) has concluded that the issue was most likely caused by residual mold-in stress that cas released when solvent was applied to the tubing attached to the outlet port and the tubing completely inserted onto the port.Sorin group usa has initiated a formal capa project to investigate the root cause for the issue and identify appropriate corrective actions.

• Brand Name: VOLUNTEER PERF KNOXVILLE TN1
• 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 ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4645000
• MDR Text Key: 20073097
• Report Number: 1718850-2015-00075
• Device Sequence Number: 1
• Product Code: DWE
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 044014100
• Device Lot Number: 1424700032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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