MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-09-28 for TERUMO KHURI MYOCARDIAL PH MONITOR 7205 manufactured by Terumo Cardiovascular Systems Corp..
[21380481]
During use of the myocardial ph sensor during cardiopulmonary bypass surgery, the sensor exhibited inaccurate ph values to an extent that could have caused the surgeon to draw incorrect conclusions about the status of the heart tissue ph. There were no adverse consequences to the pt as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023117-2005-00001 |
| MDR Report Key | 645326 |
| Report Source | 05,06 |
| Date Received | 2005-09-28 |
| Date of Report | 2005-09-28 |
| Date of Event | 2005-08-30 |
| Date Mfgr Received | 2005-09-02 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2005-11-10 |
| 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 | 0 |
| Manufacturer Contact | STEVEN ARICK |
| Manufacturer Street | 6200 JACKSON RD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7347416238 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO KHURI MYOCARDIAL PH MONITOR |
| Generic Name | INDWELLING PH SENSOR |
| Product Code | CBZ |
| Date Received | 2005-09-28 |
| Returned To Mfg | 2005-09-06 |
| Model Number | 7205 |
| Catalog Number | 7205 |
| Lot Number | 2005-12AW |
| ID Number | NA |
| Device Expiration Date | 2005-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 634814 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | * ANN ARBOR MI 48103 US |
| Baseline Brand Name | TERUMO KHURI MYOCARDIAL PH SENSOR |
| Baseline Generic Name | INDWELLING PH SENSOR |
| Baseline Model No | 7205 |
| Baseline Catalog No | 7205 |
| Baseline Device Family | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K020967 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-28 |