MAUDE Adverse Event Report: SORIN GROUP ITALIA IN00087 CLERMONT FERRAND PH; CUSTOM PERFUSION PACK

Catalog Number IN00087

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

Patient Problems Death (1802); Thrombosis (2100)

Event Date 01/31/2014

Event Type  Death  

Event Description

Sorin group (b)(4) received a report of massive clots in the perfusion circuit.It was also reported that the pt expired.

Manufacturer Narrative

Sorin group (b)(4) manufactures the involved custom perfusion pack and the inspire 6f oxygenator.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).The customer perfusion pack is not sold in the u.S.But the inspire 6f oxygenator which was a component of the pack is distributed in the u.S.The 510(k) number for the inspire 6f oxygenator is k120185.Sorin group (b)(4) received a report of massive clots in the perfusion circuit.The circuit contained an inspire 6f oxygenator.It was also reported that the pt expired.The investigation is ongoing.A follow-up report will be filed when the investigation is complete.

• Brand Name: IN00087 CLERMONT FERRAND PH
• Type of Device: CUSTOM PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri voorhees, mgr ; 14401 w 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3678572
• MDR Text Key: 20979524
• Report Number: 1718850-2014-00060
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 02/07/2014

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: IN00087
• Device Lot Number: 1311080233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 77