MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-03-22 for CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER * 942-873 manufactured by *.
[16764957]
The customer has observed small bobbles of air in the measuring chamber of their abl5, bloodgas analyzer and sometimes the measurement of the p02 value is to high, in relation to what was expected. The customer used a wroong size of capillary tubes. The analyzer requires a minimum of 85 ul to perform a correct measurement of all parameters. If the user only provides 55 ul the analyzer will not get enough blood to ensure correct measurements. This causes that the p02 value will be to high and sometimes close to the value of atmospheric air.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00020 |
| MDR Report Key | 692773 |
| Report Source | 01 |
| Date Received | 2006-03-22 |
| Date of Report | 2006-03-22 |
| Date of Event | 2006-02-17 |
| Date Mfgr Received | 2006-02-17 |
| Date Added to Maude | 2006-03-30 |
| 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 | LISE-LOTTE RINGBY, SPECIALIST |
| Manufacturer Street | AKANDVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 8273495 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER |
| Generic Name | CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2006-03-22 |
| Model Number | * |
| Catalog Number | 942-873 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 681925 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER |
| Baseline Generic Name | CAPILLARY TUBES |
| Baseline Model No | * |
| Baseline Catalog No | 942-873 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-22 |