BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG IN00197

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number9680841-2016-00167
MDR Report Key5524229
Report SourceHEALTH PROFESSIONAL
Date Received2016-03-24
Date of Report2016-03-02
Date of Event2016-03-01
Date Mfgr Received2016-03-25
Device Manufacturer Date2015-11-01
Date Added to Maude2016-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCARRIE WOOD
Manufacturer Street14401 W. 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer Phone3034676461
Manufacturer G1SORIN GROUP ITALIA
Manufacturer StreetVIA STATALE 12 NORD, 86
Manufacturer CityMIRANDOLA (MO), 41037
Manufacturer CountryIT
Manufacturer Postal Code41037
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Generic NameRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Product CodeDTN
Date Received2016-03-24
Returned To Mfg2016-03-31
Catalog NumberIN00197
Lot Number1511120026
Device Expiration Date2018-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA
Manufacturer AddressSTRADA STATALE 12 NORD, 86 MIRANDOLA (MO), ITALY 41037 IT 41037


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-24

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