MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-03 for SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR 050556 manufactured by Sorin Group Italia Srl.
[56307440]
Patient information was not provided. The vvr4000i smarxt hp reservoir (lot number 1602050118) is a non-sterile device that was assembled into a convenience pack (catalog 084118102, lot 1616500047 or 1617400034) and sterilized before distribution and use in the usa. Expiration date (mm/dd/yyyy) for both convenience pack lots: 06/30/2018. Unique identifier (udi) number for the convenience packs: lot 1616500047 - (b)(4). Lot 1617400034 - (b)(4). Device manufacture date (mm/dd/yyyy) for the convenience packs: lot 1616500047 - 06/13/2016. Lot 1617400034 - 06/22/2016. The sorin vvr 4000i smarxt 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: k092315). Sorin group (b)(4) manufactures the sorin vvr 4000i smarxt hardshell venous reservoir. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that, during a procedure, the blue cap on the cardiotomy port was blown off due to over-pressurization of the sorin vvr 4000i smarxt hardshell venous reservoir. Blood and foam were sprayed in the operation room. The reservoir was changed out and the bypass was re-initiated. Reportedly the event occurred while the patient was off by-pass. At the end of the procedure, the patient was put in ecmo and transferred in icu. The patient died after the procedure. The cause of death is unknown, however the perfusionist has stated that it is not believed the outcome of the patient is associated with the failure of the device. The device has been returned to sorin group (b)(4) and the investigation is in progress. A follow-up report will be sent when the investigation has been completed. Device returned, not yet decontaminated.
Patient Sequence No: 1, Text Type: N, H10
[56307441]
Sorin group (b)(4) received a report that, during a procedure, the blue cap on the cardiotomy port was blown off due to over-pressurization of the sorin vvr 4000i smarxt hardshell venous reservoir. Blood and foam were sprayed in the operation room. The reservoir was changed out and the bypass was re-initiated. Reportedly the event occurred while the patient was off by-pass. At the end of the procedure, the patient was put in ecmo and transferred in icu. The patient died after the procedure. The cause of death is unknown, however the perfusionist has stated that it is not believed the outcome of the patient is associated with the failure of the device.
Patient Sequence No: 1, Text Type: D, B5
[65276643]
Sorin group (b)(4) manufactures the sorin vvr 4000i smarxt hardshell venous reservoir. The incident occurred in (b)(6). Visual inspection of the reservoir at sorin group usa identified residual blood still inside the unit. No defects or abnormalities were detected. The device was returned to sorin group (b)(4) for further investigation, where simulated use testing found that the cardiotomy filter of the reservoir was partially occluded by clotted blood or biological material from the surgical field. However, no non conformities were noted during the control and testing phases. Sorin group (b)(4) has concluded that the most probable root cause of the event is associated with the filtration clotting phenomenon triggered by multiple factors such as patient blood features, clinical procedure and use condition. The use of co2 during the procedure, as described by the customer, can also trigger aggregate phenomena. Additionally, prolonged use of the device is not recommended per the instructions for use (ifu). Based on the pump sheet data for the event, the reservoir was used for 1. 5 hours longer than the recommended use time. A dhr review confirmed that the device was manufactured, tested and released in compliance with standard manufacturing procedures. According to traceability, no other complaints have been received for this lot. Based on the result of the investigation, no corrective action has been deemed necessary. Sorin group (b)(4) will continue to monitor for this type of issue.
Patient Sequence No: 1, Text Type: N, H10
[71335484]
On march 6, 2017, sorin group (b)(4) learned that a user medwatch report ((b)(4)) was filed by the initial reporter for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2016-00500 |
| MDR Report Key | 5993802 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-03 |
| Date of Report | 2017-03-30 |
| Date of Event | 2016-09-03 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2016-10-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAN CEASAR |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Street | STRADA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA (MODENA) 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2016-10-03 |
| Returned To Mfg | 2016-09-29 |
| Catalog Number | 050556 |
| Lot Number | 1602050118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA SRL |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA (MODENA) US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-10-03 |