MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE 03497 manufactured by Sorin Group Italia.
[114557870]
Patient was not involved. The d131 dideco kids infant arterial filter is a non-sterile device assembled into a sterile convenience pack (lot 1511090048) that is not distributed in the usa. The expiration date refers to the sterile finished product into which the arterial filter was assembled. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. The age of the device was calculated as the time elapsed between device sterilization and the date of event. (b)(4). The complained d131 dideco kids infant arterial filter is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone arterial filter (catalog number 050542) is registered in the usa. The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the arterial filter was assembled. Sorin group (b)(4) manufactures the d131 dideco kids infant arterial filter. 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. This mdr has been already submitted july 10, 2018 and resubmitted due to missing 3rd acknowledgment. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[114557871]
Sorin group (b)(4) received a report that the blood outlet connector of the d131 arterial filter completely broke off during set-up. The issue occurred prior to patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680841-2018-00018 |
| MDR Report Key | 7689122 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-06-10 |
| Date Facility Aware | 2018-06-12 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2018-07-16 |
| 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 | D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-07-16 |
| Catalog Number | 03497 |
| Lot Number | 1510060162 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 31 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-16 |