MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2013-07-11 for SHUNT SENSOR SYS500 CDI510H NA manufactured by Terumo Cardiovascular Systems Corp..
[21672175]
The user facility reported to terumo cardiovascular system that during cardiopulmonary bypass surgery, the shunt sensor leaked. Less than 1cc blood loss. Product was changed out. Surgery was successful.
Patient Sequence No: 1, Text Type: D, B5
[21913225]
Upon eval of the device, the complaint was confirmed. The unit was performance tested, and the behavior of the unit was indicative of a leak. Visual inspection of the unit found that the dome was missing from the ph chemistry position. A review of the device history record could not be performed, as the lot number is unk. The most probable cause of the leak is that this particular unit was on the lower side of the adhesive injection volume for the primary adhesive ring. This unit was sufficiently cured and sealed to pass through our 100% leak test, but not enough to survive shipping, handling, and temperature/pressure changes. The most probable reason for the dome detachment is from shear stress inflicted by a pointed object that left marks on the polycarbonate. (b)(4). All available info has been placed on file in quality management for appropriate tracking, trending and follow up.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124841-2013-00141 |
| MDR Report Key | 3227128 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-06-24 |
| Date of Event | 2013-05-18 |
| Date Mfgr Received | 2013-06-24 |
| Date Added to Maude | 2013-10-02 |
| 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 | MICHAEL SILVESTRI, QUALITY DIR |
| 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 CORP. |
| 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 | SHUNT SENSOR SYS500 |
| Generic Name | BLOOD-GAS MONITOR |
| Product Code | DTY |
| Date Received | 2013-07-11 |
| Returned To Mfg | 2013-06-27 |
| Model Number | CDI510H |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 125 BLUE BALL RD. ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-11 |