| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AFFIRM VPIII LYSIS BLOCK 120V | THERMO SCIENTIFIC | JQW | 10804-001 | 211890 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-11-21 | 0 | 1. R |
Patient 1
CUSTOMER CONTACTED BD ON (B)(6) 2013, TO REPORT THAT THEIR AFFIRM VPIII LYSIS BLOCK HAD STOPPED WORKING. THE CUSTOMER HEARD A "POP" SOUND AND SAW A SMALL PUFF OF SMOKE COME FROM THE LYSIS BLOCK. THE CUSTOMER DID NOT SEE ANY FLAMES. THE CUSTOMER FOUND THE AFFIRM LYSIS BLOCK SHOWED SIGNS OF OVER HEATING AND BLACKENED AND MELTED THE COUNTER TOP UNDERNEATH IT. THE CUSTOMER IMMEDIATELY UNPLUGGED THE BLOCK AND CONTACTED BD TECHNICAL SERVICE.
Patient 1
THE AFFIRM VPIII LYSIS BLOCK IS USED TO PROVIDE A CONTROLLED A 85 DEGREES C DRY HEAT ENVIRONMENT FOR AFFIRM MICROBIAL IDENTIFICATION TEST SAMPLE COLLECTION TUBES CONTAINING A SPECIMEN AN REAGENT SOLUTION FOR IN VITRO DIAGNOSTIC USE. THE AFFIRM VPIII LYSIS BLOCK IS PROVIDED AS COMPONENT OF THE BD MICROPROBE PROCESSOR SYSTEM. THE BD QUALITY DEPARTMENT VISUALLY INSPECTED THE RETURNED AFFIRM VPIII LYSIS BLOCK AND CONFIRMED THE CUSTOMER COMPLAINT. THE RETURNED LYSIS BLOCK WAS FOUND TO HAVE BLACK DISCOLORATION AND PORTIONS OF THE CASING WERE MELTED, WARPED OR BURNED. FURTHER INVESTIGATION FOUND THAT TWO ELECTRICAL INPUT WIRES WERE NO LONGER ATTACHED TO THE BOARD. AN ELECTRICAL FAULT HAD BURNED THE TWO LEADS AWAY FROM THE BOARD. BD QUALITY WAS UNABLE TO DETERMINE ROOT CAUSE AND HAS FORWARDED THE LYSIS BLOCK AND COMPLAINT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. COMPLAINT TRENDING WAS PERFORMED. THERE IS NO TREND ON THIS TYPE OF DEFECT NOTED. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. BD WILL CONTINUE TO TREND ON THIS TYPE OF EVENT.