MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-13 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular Systems Corp..
[3878064]
It was reported that during priming of the device for a cardiopulmonary bypass procedure, the a/d (analog to digital conversion) test failed on the blood parameter monitor (bpm). As a result, an alternate device was employed. The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[11127285]
This complaint was confirmed by the product surveillance lab tech. The a/d (analog to digital conversion) test failure error was observed and was occurred during the power up self-test. Visual inspection found a cracked battery that had leaked acid. The battery leaking was confirmed to have reached the pcba. Battery acid has damaged the circuits and was present on the circuit board. The battery acid was considered to have caused the a/d failure on the pcba. This product is being phased out in the global market. Service and replacement parts are no longer available. If add'l info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00866 |
| MDR Report Key | 3396396 |
| Report Source | 05,06 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-09-06 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-09-06 |
| Date Added to Maude | 2013-12-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAN WINDER |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48103 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 100 MONITOR |
| Product Code | DTY |
| Date Received | 2013-09-13 |
| Returned To Mfg | 2013-06-17 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 6200 JACKSON RD. ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-13 |