BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Report
- Report Number
- 9680841-2018-00023
- Event Type
- Malfunction
- Date Received
- July 25, 2018
- Date of Event
- July 4, 2018
- Report Date
- November 15, 2018
- Manufacturer
- SORIN GROUP ITALIA
- Product Code
- DTN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
THE BMR 1900L PHISIO CLOSED VENOUS RESERVOIR BAG IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1803270092) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE BAG WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. (B)(6) THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED BMR 1900L PHISIO BAG IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE BAG (CATALOG NUMBER 969000223) IS REGISTERED IN THE USA (510(K) NUMBER: K112771). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE BAG WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900L PHISIO CLOSED VENOUS RESERVOIR BAG. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SORIN GROUP ITALIA MANUFACTURES THE BMR 1900L PHISIO CLOSED VENOUS RESERVOIR BAG. THE INCIDENT OCCURRED IN GENT, BELGIUM. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED BAG WAS RETURNED TO SORIN GROUP ITALIA WITH THE CONNECTOR COMPLETELY DETACHED. THE TUBE WAS RECONNECTED WITHOUT ADDITIONAL BONDING AND A LEAK TEST WAS PERFORMED BY FILLING THE BAG, MOUNTING IT ON THE DEDICATED BRACKET AND PRESSURIZING THE BAG TO 0.8 BAR FOR 15 MINUTES (THE PRODUCT IFU RECOMMENDS 0.1 BAR). THE LEAK TEST CONFIRMED A LEAK BETWEEN THE TUBE AND THE CONNECTOR OF THE INLET LINE. NO DISCONNECTION WAS OBSERVED. A REVIEW OF THE DHR DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. INTERNAL INVESTIGATION SUGGESTED THAT THE ROOT CAUSES OF THE REPORTED LEAK ARE A SMALL DEFORMATION OF THE TUBE AND A NON-HOMOGENEOUS DISTRIBUTION OF SOLVENT AT THE LEAKING POINT. BASED ON ADDITIONAL INFORMATION RECEIVED AS PART OF THE INVESTIGATION PERFORMED, NO ACTUAL DISCONNECTION OCCURRED AT CUSTOMER SITE. THE CUSTOMER VOLUNTARILY DETACHED THE TUBING FROM THE CONNECTION. THIS EVENT HAS NO POTENTIAL TO CAUSE SERIOUS INJURY. ALTHOUGH THE FREQUENCY OF THIS TYPE OF EVENT IS VERY LOW AND THE RISK ASSOCIATED IS LOW, SORIN GROUP ITALIA ADJUSTED THE TOOL USED TO ENLARGE THE TUBE DURING THE INSERTION OF THE CONNECTOR TO PREVENT POSSIBLE TUBING DEFORMATION DURING MANUFACTURING. IN ADDITION, SORIN GROUP ITALIA HAS BEGUN PERFORMING IN-PROCESS PEEL TESTING BEFORE BATCH RELEASE. CORRECTIVE ACTIONS HAVE ALSO BEEN INITIATED TO EVALUATE IMPLEMENTATION OF ADDITIONAL MITIGATION.
SORIN GROUP (B)(4) RECEIVED A REPORT THAT A LEAK NEAR THE INLET CONNECTOR OF THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG WAS OBSERVED DURING PRIMING. THE CUSTOMER REPORTED THAT THE LEAKING CONNECTOR COULD BE EASILY DETACHED FROM THE BAG AFTER HAVING BEEN PRIMED AT HIGH PRESSURE WITH WARM PRIMING SOLUTION. THERE WAS NO PATIENT INVOLVEMENT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561154 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS | DTN | SORIN GROUP ITALIA | 1801230069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |