MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00723

Device Problem Device Issue (2379)

Patient Problem Death (1802)

Event Date 11/10/2016

Event Type  Death  

Manufacturer Narrative

The complained inspire 8f hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is not distributed in the usa.The catalog number, lot number, and expiration date refer to the sterile finished product into which the oxygenator was assembled.As the sterile finished product is not distributed in usa, there is no unique identifier (udi) number.However, the complained device is similar to inspire 8f oxygenator catalog number 050716, which is distributed in the usa, for which the device identifier is (b)(4).The complained inspire 8f hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050716) is registered in the usa (510(k) number: k130433).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been requested for return to sorin group (b)(4) for investigation.However, it has not yet been returned.The investigation is on-going.A follow-up report will be sent when the investigation will be completed.

Event Description

Sorin group (b)(4) received a report that two air bubble alarm events occurred and stopped the main pump during a mitral valve repair procedure.The two alarms occurred within ten minutes of each other and were promptly resolved.At the end of the procedure, the perfusionist identified white matter (reported to be fibrin) in the integrated arterial filter of the inspire 8f hollow fiber oxygenator.The patient did not regain consciousness following the procedure and expired on (b)(6) 2016.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).The involved device was returned to sorin group (b)(4) for investigation.The oxygenator device was found to be conforming to specifications.No anomalies related to the complained event were identified, and no similar reports of deposits in the arterial filter have been reported for the complained lot.An attempt to identify the origin of the deposit was made through a histological examination.However, due to poor preservation of the biological substances, a definitive conclusion could not be reached.Through follow-up communication.Sorin group (b)(4) learned that a maneuver to divert the deposit in the arterial filter was reportedly attempted during the case.This kind of maneuver has no proven efficacy and could have increased the likelihood of solid emboli release to the patient.For this type of situation, the instruction for use recommends an oxygenator replacement.A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; miradola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6167136
• MDR Text Key: 62138015
• Report Number: 9680841-2016-00519
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: IN00723
• Device Lot Number: 1605310056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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: 70 YR
• Patient Weight: 60