MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-24 for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG IN00197 manufactured by Sorin Group Italia.
[41120184]
There was no patient involvement. At the date of the present report, the unit has not been returned to sorin group (b)(4) for investigation. The bmr 1900 l phisio was assembled into a customized product (catalog number in00197) that is not distributed in the usa, but it is similar to the bmr 1900 l phisio venous reservoir bag (catalog number 00398), which is distributed in the usa (510(k) number: k112771). Sorin group (b)(4) manufactures the bmr 1900 l phisio. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that the outlet connector of the venous reservoir bmr 1900 l phisio broke off following a procedure. As the event occurred after the procedure, there was no patient involvement. The investigation is on-going. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[41120185]
Sorin group (b)(4) received a report that the outlet connector of the venous reservoir bmr 1900 l phisio broke off following a procedure. As the event occurred after the procedure, there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[43297386]
Sorin group (b)(4) manufactures the bmr 1900 l phisio. The incident occurred in (b)(6). This medwatch is being filed on behalf of sorin group (b)(4). Sorin group received a report that the outlet connector of the venous reservoir bmr 1900 l phisio broke off following a procedure. As the event occurred after the procedure, there was no patient involvement. The complained unit was returned to sorin group (b)(4) for further investigation where it underwent visual inspection. The inspection found that the breakage of the connector seemed to occur as a result of an unusual tear-down operation done in an orthogonal direction with respect to the backplate. Use simulation suggested that the force to induce breakage is significantly higher than the normal force applied to set-up and tear-down the bag to and form the bracket. In order to improve the resistance of the connectors to mechanical stress, a capa was initiated and the length of the pvc tubing has been increased by 4mm. This change permits a reduction of the pull force to be applied to the connectors during the set-up and tear-down of the bag without impacting the positioning of the bag onto the bracket. An additional capa was also initiated to guarantee a correct distribution of the solvent during the gluing phase. To achieve this, a semi-automatic equipment which avoids excessive distribution of the bonding agent was introduced in the manufacturing area in march, 2016. The involved unit was manufactured before implementation of the above corrective actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2016-00167 |
| MDR Report Key | 5524229 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-03-01 |
| Date Mfgr Received | 2016-03-25 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-03-24 |
| 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 | CARRIE WOOD |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP ITALIA |
| Manufacturer Street | VIA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA (MO), 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 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2016-03-24 |
| Returned To Mfg | 2016-03-31 |
| Catalog Number | IN00197 |
| Lot Number | 1511120026 |
| Device Expiration Date | 2018-10-31 |
| 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 |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA (MO), ITALY 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-24 |