MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-22 for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG 00398 manufactured by Sorin Group Italia S.r.l..
[67927245]
There was no patient involvement. The bmr1900 ph. I. S. I. O venous reservoir bags (item 00398, lot number 1605250167) are non-sterile devices that are assembled into convenience packs for sterilization and distribution in the usa. The lot number of the convenience pack was not reported by the customer, so the expiration date and device identifier (udi) number could not be determined. However, the customer reported that the bags belonged to the same lot of convenience pack. Approximate age of device: as the manufacturing date of the convenience pack cannot be determined, the approximate age of device could not be determined (b)(4). The bmr1900 ph. I. S. I. O venous reservoir bags were assembled into a convenience packs distributed in the usa. The non-sterile the bmr1900 ph. I. S. I. O venous reservoir bag is also distributed in the usa (510(k) number: k112771). As the lot number has not been provided, the device manufacture date is unknown. Sorin group (b)(4) manufactures the bmr1900 ph. I. S. I. O venous reservoir bags. The incident occurred in (b)(6). (b)(4). A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue. The devices have been requested for return to sorin group (b)(4) for investigation. A follow-up report will be sent once the investigation is complete. Device not yet returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[67927246]
Sorin group (b)(4) received a report that the bmr1900 venous reservoir bag leaked from the outlet while dismounting the bag during priming. The leak occurred when outlet connector detached from the bag. The issue reportedly occurred twice, and both bags belonged to the same convenience pack lot number. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[75633386]
(b)(4). (b)(4) manufactures the bmr1900 ph. I. S. I. O venous reservoir bags. The incident occurred in (b)(6). (b)(4). Two devices were returned to sorin group (b)(4) for investigation. Visual inspection of the one of the devices revealed that the outlet connector was completely detached. No trace of adhesive was visible. The connector of the second device was connected. This device was leak tested and no leaks were observed. Based on the results of the investigation, sorin group (b)(4) believes that the most probable root cause of the connector detachment is an incomplete gluing process during manufacturing. The relevant manufacturing floor personnel have been made aware of the event to prevent recurrence. A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue. No similar complaints related to this lot have been reported. This even is considered to be an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2017-00004 |
| MDR Report Key | 6348393 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-22 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-01-25 |
| Date Facility Aware | 2017-01-26 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-02-22 |
| 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 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2017-02-22 |
| Model Number | 00398 |
| Lot Number | 1605250167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA (MODENA) US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-22 |