MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-25 for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG 00398 manufactured by Sorin Group Italia.
[115405307]
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). (b)(4). If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[115405308]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680841-2018-00023 |
| MDR Report Key | 7717972 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-25 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-07-04 |
| Date Facility Aware | 2018-07-04 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2018-07-25 |
| 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 SRL |
| 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 | 2018-07-25 |
| Returned To Mfg | 2018-07-16 |
| Catalog Number | 00398 |
| Lot Number | 1801230069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| 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, MODENA 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-25 |