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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number D902
Device Problems Leak/Splash (1354); Low Readings (2460); Device Operational Issue (2914)
Patient Problem Sepsis (2067)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier was not provided. The age of the device was calculated as the time elapsed between device sterilization and the date of the event. (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report; device not yet returned.
 
Event Description
Sorin group italia received a report that the po2 values dropped to 43. 6 mmhg and blood droplets were noticed coming out from the lilliput 2 infant hollow fiber oxygenator gas vent port 10 minutes into a procedure. The medical team elected to change out the oxygenator and the procedure was completed with no further issues. During follow-up communication with the customer, the patient developed sepsis and the icu stay was prolonged 14 days.
 
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Brand NameLILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer (Section G)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key7649500
MDR Text Key112868666
Report Number9680841-2018-00016
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K971877
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,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2020
Device Model NumberD902
Device Catalogue Number05324
Device Lot Number1709210228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/04/2018
Device Age8 MO
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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