MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-04-20 for SAFECLINITUBES D941P-NA-240-85 X 3 942-891 manufactured by Radiometer Medical Aps..
[2810675]
An abl835 analyzer reported results of blood sample measurements of neonatal pts with an increased ca value of app. 0, 3 mmol/l higher than expected when measurements were performed on capillary blood samples using radiometer plastic capillary tubes.
Patient Sequence No: 1, Text Type: D, B5
[9822389]
On this neonatal department they have had two different types of plastic capillary tubes, i. E. Safeclinitubes d941p-na-240-85 x 3, part no. 942-891, and safeclinitubes d957p-70-100 x 1, part no. 942-892. These two types of plastic capillaries were mixed up by the users (nurses and physicians) when blood sample measurements have been performed. They have used the capillary type which contains sodium heparin when they performed blood sample measurements to get electrolyte results. This is a use error. We have reviewed the package labeling and insert for the safeclinitubes (attached). Both the package and the insert states which type of heparin the tubes contain. Furthermore the abl835 analyzer operators manual contains the following caution (p. 1-5 'limitations of use and known interfering substances,'): 'anticoagulants that contain sodium salts will give erroneously high cna+ results. Sodium fluoride with or without edta and oxalate (di na) influence cglu results. Sodium fluoride gives erroneously high cna+ and low cca2+, cglu and clac results. Tri sodium citrate influences cna+, ck+ and cglu results. '
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2012-00006 |
| MDR Report Key | 2546839 |
| Report Source | 01,05 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-03-27 |
| Date Added to Maude | 2012-09-13 |
| 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 | LASSE MOLLER, SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFECLINITUBES |
| Generic Name | PLASTIC CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2012-04-20 |
| Model Number | D941P-NA-240-85 X 3 |
| Catalog Number | 942-891 |
| Lot Number | DW 01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS. |
| Manufacturer Address | BRONSHOJ DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-20 |