MAUDE Adverse Event Report: SORIN GROUP ITALIA D130 PH.I.S.I.O. DIDECO KIDS NEONATAL ARTERIAL FILTER W/40 MICRON SCREEN PHOSPHO; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 03492

Device Problem Component(s), broken (1103)

Patient Problem No Patient involvement (2648)

Event Date 12/05/2013

Event Type  Other  

Event Description

Sorin group received a report that the outlet port of the dideco kids neonatal arterial filter was found to be broken off during set up.The filter was replaced and the procedure was completed with no further issue.There was no patient involvement.

Manufacturer Narrative

Sorin group(b)(4) manufactures the d130 ph.I.S.I.O.Dideco kids neonatal arterial filter w/40 micron screen phosphosphorylcholine coated.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that the outlet port of the dideco kids neonatal arterial filter was found to be broken off during set up.The filter was replaced and the procedures was completed with no further issues.There was no patient involvement.The filter was returned to sorin group usa for evaluation.Visual inspection of the filter confirmed the blood outlet port was broken off at the base.Inspection under ultra violet light showed evidence of solvent bonding of the port, but no evidence of excess solvent or pooling was seen.No significant whitening or deformation was observed in the material at the break site.A review of the device history record did not reveal any deviations or nonconformities related to the failure.The tubing to connector processes at sorin group (b)(4) and sorin group usa are being evaluated and a capa project has been opened to determine the root cause of the failure and identify appropriate corrective actions.

• Brand Name: D130 PH.I.S.I.O. DIDECO KIDS NEONATAL ARTERIAL FILTER W/40 MICRON SCREEN PHOSPHO
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; 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: 3628050
• MDR Text Key: 4177748
• Report Number: 1718850-2014-00002
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063255
• 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: 01/03/2014

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: 04/30/2014
• Device Catalogue Number: 03492
• Device Lot Number: 1305240055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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