BM14 FLUID UF MODULE FOR BM25
Received Jun 22, 2011 · Event occurred Jan 27, 2011
Report 1423500-2011-08137 · MDR key 2136889
Device
Generic name
Pump, Blood, Extra-luminal
Manufacturer
Edwards Lifesciences Germany GmbhCatalog number
5M3052FR
Product problems
- Loss of Power
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE ACTUAL INSTRUMENT WAS RECEIVED, EVALUATED AND REPAIRED. THE ROOT CAUSE WAS THE POWER SUPPLY BOARD (230 VOLTS). TRANSPORTATION CAUSED SEVERAL CONDENSERS AND DIODES TO LOOSEN, RESULTING IN VOLTAGE FLUCTUATIONS AND SPARKING. THUS, IT WAS NOT POSSIBLE TO ESTABLISH CORRECT COMMUNICATION WITH BM14. THIS, IN TURN, CAUSED THE BM14 TO SWITCH OFF AGAIN, SINCE IT IS CONTROLLED VIA THE BM11.
Description of Event or Problem
A CUSTOMER REPORTED TO BAXTER THAT AFTER INITIAL START UP OF THE BM25, THE BM14 SHUT OFF AFTER 30 SEC. THE INSTRUMENT COULD NOT BE USED FOR THE PATIENT TREATMENT. NO PATIENT INVOLVEMENT. THE INSTRUMENT WILL BE RETURNED FOR INVESTIGATION/REPAIR.