MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

The complained inspire 8f m oxygenator was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa.The expiration date refers 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 involved device is similar to inspire 8f m oxygenator catalog number 050703, which is distributed in the usa, for which the device identifier is (b)(4).The date provided is the date the device was returned to sorin group (b)(4) after gamma ray decontamination.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The awareness date indicated is the date that the additional information regarding drug administration to the patient was provided by the customer.Pma 510(k): the inspire 8f m oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050703) 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 m hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).The involved device was returned to sorin group (b)(4) for investigation.The device was submitted to testing for verification of the transmembrane pressure drop and test results found that the measured pressure drop values were within the device specification.The device was found performing as expected.As the issue was not reproduced, a root cause was not determined.However, based on the evidence from previously investigated cases, sorin group (b)(4) believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.

Event Description

Sorin group (b)(4) received a report that the pre-oxygenator pressure of the inspire 8f m hollow fiber oxygenator continuously increased above 550 mmhg during a procedure.The high pressure was compensated for by reducing the blood flow to under 4 lpm.During follow-up communication on (b)(6), it was learned that the pressure also had to be regulated through administration of drugs to the patient.There was no report of patient injury.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strata statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: joan caesar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6819905
• MDR Text Key: 83671965
• Report Number: 9680841-2017-00024
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03705
• Device Lot Number: 1702270005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 MO
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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): Required Intervention