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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIPULMONARY BYPASS

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SORIN GROUP ITALIA INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIPULMONARY BYPASS Back to Search Results
Catalog Number 03717
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Additional device information: lot number: two reservoir lot numbers, 1602030201 and 1602080148, were provided. It is unknown which of these lot numbers the involved device belongs to. These lot numbers are for non-sterile reservoir units. The reservoir is assembled into a convenience pack and sterilized before distribution. Because the lot number of the convenience pack was not provided by the customer, no expiration date or unique identifier (udi) number can be determined. Device manufacture date (mm/dd/yyy): the following manufacture dates are for the non-sterile inspire hardshell venous/cardiotomy reservoir. Lot 1602030201 - 02/04/2016, lot 1602080148 - 02/08/2016. The inspire hardshell venous/cardiotomy reservoir was assembled into a convenience pack distributed in usa. The non-sterile reservoir is also distributed in the usa as a sterile device (510(k)number: k130433). Sorin group (b)(4) manufactures the inspire hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the inspire hardshell venous/cardiotomy reservoir did not provide adequate vacuum to drain the heart upon initiation of cpb. The vacuum level was increased and the user reported that the reservoir over/under safety valve fell into the reservoir. The surgeon elected to cover the hole and to continue the procedure. At the end of the bypass, the blood outlet connector of the reservoir was occluded by the detached over/under safety valve, preventing blood transfusion into the patient. There was no report of patient injury. The complained inspire hvr was not returned to sorin group (b)(4) for investigation. Follow-up communication with the customer was unable to clarify the vacuum level that was applied to the reservoir before the detachment of the valve. Detachment of the valve from its seat due to an exceedingly high vacuum level above the recommended value stated in the ifu could not be excluded as a potential root cause. A review of the dhr for both reported lots did not identify any deviations or non-conformities relevant to the reported issue. The product was manufactured in accordance with the defined specifications. The investigation could not identify how the over/under pressure valve became detached. Although the incident rate for this type of issue is very low, sorin group (b)(4) initiated a capa in 2015 to implement corrective actions for preventing valve detachment caused by accidental collision with the device. As part of the corrective actions, the label of the over/under pressure valve has been modified to better clarify to users that pressing the valve should be avoided. Additionally, a diaphragm has been added on top of the valve to prevent the valve from falling into the reservoir in the event that it becomes detached. Both of the reported lots were manufactured before implementation of the diaphragm. A design change of the valve seat to further reduce the potential for the over/under pressure valve to become detached is in process.
 
Event Description
Sorin group (b)(4) received a report that the inspire hardshell venous/cardiotomy reservoir did not provide adequate vacuum to drain the heart upon initiation of cpb. The vacuum level was increased and the user reported that the reservoir over/under safety valve fell into the reservoir. The surgeon elected to cover the hole and to continue the procedure. At the end of the bypass, the blood outlet connector of the reservoir was occluded by the detached over/under safety valve, preventing blood transfusion into the patient. There was no report of patient injury.
 
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Brand NameINSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
Type of DeviceOXYGENATOR, CARDIPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola (mo), 41037
IT 41037
Manufacturer (Section G)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola (mo), 41037
IT 41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5807461
MDR Text Key49956096
Report Number9680841-2016-00478
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03717
Device Lot Number1602030201 OR 1602080148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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