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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA D901 LILLIPUT OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA D901 LILLIPUT OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 05319
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information were not provided. The expiration date refers to the sterile finished product. The complained d901 dideco lilliput phisio oxygenator (catalog number 05319, lot 2011090114) is not distributed in the usa, therefore the udi is not applicable. The oxygenator item 05319 is similar to the complained d901 dideco lilliput phisio oxygenator item 05316, which is distributed in the usa, for which the device identifier is (b)(4). The product item 05319 is not distributed in the usa, but it is similar to the d901 dideco lilliput phisio oxygenator item 05316, which is distributed in the usa (510(k) number: k953835). The device manufacture date refers to manufacture date of the sterile, finished oxygenator. Sorin group (b)(4) manufactures the d901 dideco lilliput phisio oxygenator. The incident occurred in (b)(6). The involved device has not 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.
 
Event Description
Sorin group (b)(4) has received a report that, during a procedure, the d901 dideco lilliput phisio oxygenator was leaking. Medical team elected to change-out the oxygenator. There is no report of any patient injury.
 
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Brand NameD901 LILLIPUT OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola 41037
IT 41037
MDR Report Key12621912
MDR Text Key282848638
Report Number9680841-2021-00027
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05319
Device Lot Number2011090114
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

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