MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-09-15 for ABL 700 SERIES ABL 735 * manufactured by Radiometer Medical Aps.
[411718]
The customer performed a decontamination procedure on the analyzer, disregarding the screen warning: "warning: glucose, lactate and chloride electrodes should be replaced with dummy electrodes before proceeding. " the customer left the active electrodes in place during the decontamination procedure damaging the electrodes in question thus causing faulty pt values when the analyzer was subsequently used. Originally the hosp alleged that the faulty values resulted in incorrect treatment contributing to a pt death. The hosp later stated that the reported connection between the results from the analyzer and the death of a pt was a misunderstanding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00012 |
| MDR Report Key | 636044 |
| Report Source | 05,06 |
| Date Received | 2005-09-15 |
| Date of Report | 2004-12-10 |
| Date Mfgr Received | 2003-02-21 |
| Date Added to Maude | 2005-09-22 |
| 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 | LEIF GUDNITZ |
| Manufacturer Street | AKANDEVEJ 21, |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3002807-12/10/2004-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 700 SERIES |
| Generic Name | BLOOD GAS ANALYZER WITH ADDITIONAL PARAMETER |
| Product Code | CCE |
| Date Received | 2005-09-15 |
| Model Number | ABL 735 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 625586 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | ABL 700 SERIES |
| Baseline Generic Name | BLOOD GAS ANALYZER WITH ADDITIONAL PARAMETER |
| Baseline Model No | ABL 735 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-15 |