MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-01-11 for BUBBLE TRAP HOLDER 1XX*XH041 NA manufactured by Terumo Cardiovascular Systems Corporation.
[2431384]
The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass surgery, it was noticed that the ring that holds the arterial filter was cracking. The product was not changed out. There was no patient injury. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[9582141]
Terumo has not received the actual device for investigation; therefore, terumo is still investigating this issue, and a follow-up report will be submitted when the investigation is completed and more information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681834-2012-00003 |
| MDR Report Key | 2417871 |
| Report Source | 05,06,07 |
| Date Received | 2012-01-11 |
| Date of Report | 2011-03-18 |
| Date of Event | 2011-03-18 |
| Date Facility Aware | 2011-03-18 |
| Report Date | 2011-03-18 |
| Date Mfgr Received | 2011-03-18 |
| Date Added to Maude | 2012-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL SILVESTRI, DIRECTOR |
| Manufacturer Street | 125 BLUE BALL RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002623304 |
| Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Street | 125 BLUE BALL RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUBBLE TRAP HOLDER |
| Generic Name | BUBBLE TRAP HOLDER |
| Product Code | KRL |
| Date Received | 2012-01-11 |
| Model Number | 1XX*XH041 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL RD. ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-11 |