LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
Report
- Report Number
- 9680841-2022-00008
- Event Type
- Malfunction
- Date Received
- January 25, 2022
- Date of Event
- December 20, 2021
- Report Date
- May 25, 2022
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D901 LILLIPUT W/VENO OXYGENATOR (CATALOG NUMBER 05319, LOT 1911260041) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 05319 IS SIMILAR TO THE LILLIPUT 1 NEW BORN OXYGENATOR CATALOGUE 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 AND IT IS SIMILAR TO THE LILLIPUT 1 NEW BORN OXYGENATOR CATALOGUE 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 ITALIA MANUFACTURES THE LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THE OXYGENATOR IS AVAILABLE AND HAS BEEN REQUESTED FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
LIVANOVA RECEIVED A REPORT OF WATER LEAK BETWEEN THE LILLIPUT OXYGENATOR AND THE DEDICATED HOLDER DURING PRIMING OF WATER COMPARTMENT OF THE OXYGENATOR. AT THE SUBMISSION OF THE CASE, A VIDEO WAS PROVIDED, AND THE LEAKAGE IS CONFIRMED BASED ON THE PROVIDED EVIDENCE. VERIFICATION OF MANUFACTURING RECORDS POINTED OUT THAT ALL OXYGENATOR UNITS WERE RELEASED AS CONFORMING ACCORDING TO SPECIFICATIONS. ANALYSIS OF THE LIVANOVA COMPLAINTS DATABASE REVEALED OTHER SIMILAR EVENTS RELATED TO DIFFERENT PRODUCT LOTS. COMPLAINED UNITS WERE DECLARED AVAILABLE FOR INVESTIGATION AND WERE REQUESTED FOR FUNCTIONAL TESTING. DESPITE SEVERAL REMINDERS, UNITS HAVE NOT BEEN RECEIVED. THEREFORE, NO PHYSICAL INVESTIGATION IS POSSIBLE YET. BASED ON INVESTIGATION OF PREVIOUS EVENTS, THE REPORTED ISSUE COULD BE DUE TO: (I) DAMAGE IN THE HEAT EXCHANGER METAL SHEET, ALLOWING THE PASSAGE OF FLUID FROM OXYGENATOR WATER COMPARTMENT TO BLOOD COMPARTMENT. HOWEVER, IN THE VIDEO PROVIDED BY THE CUSTOMER, NO FLUID COULD BE DETECTED IN THE BLOOD COMPARTMENT OF THE OXYGENATOR. (II) DAMAGE OF THE O-RINGS OF THE HOLDER(S) THUS ALLOWING FLUID TO LEAK IN BETWEEN THE HOLDER AND THE OXYGENATOR. HOWEVER, THE CUSTOMER REPORTED THE HOLDERS DID NOT PRESENT ANY OBVIOUS PROBLEM. (III) INCORRECT MANUAL ASSEMBLY OF THE OXYGENATOR WITH THE DEDICATED HOLDER BY USER IF THE COMPLAINED UNITS WILL BE RECEIVED, THEY WILL BE INVESTIGATED. IN THE CASE OF NEW FINDINGS, EVENT RECORD WILL BE UPDATED. SINCE NO SPECIFIC ROOT CAUSE WAS IDENTIFIED AND THE RISK IS IN THE ACCEPTABLE REGION, NO CORRECTION ACTION WAS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.
SORIN GROUP ITALIA RECEIVED A REPORT THAT, DURING PRIMING OF THE WATER COMPARTMENT, A LEAK WAS OBSERVED FROM THE LILLIPUT OXYGENATOR. AT THE SUBMISSION OF THE CASE, A VIDEO OF THE FAILURE WAS PROVIDED. VISUAL INSPECTION OF THE PROVIDED VIDEO DID NOT CLARIFY IF WATER ENTERED THE RESERVOIR WHEN PRIMING THE WATER SIDE OF LILLIPUT OXYGENATOR.THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.
SEE INTIAL REPORT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687891 | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 1911260041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |