MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-21 for AFFIRM VPIII LYSIS BLOCK 120V 10804-001 211890 manufactured by Thermo Scientific.
[3983664]
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 Sequence No: 1, Text Type: D, B5
[11512705]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00011 |
| MDR Report Key | 3634376 |
| Report Source | 05 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-10-23 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2014-05-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | THERMO SCIENTIFIC |
| Manufacturer Street | 2555 KERPER BLVD |
| Manufacturer City | DUBUQUE IA 52001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 52001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII LYSIS BLOCK 120V |
| Product Code | JQW |
| Date Received | 2013-11-21 |
| Returned To Mfg | 2013-10-30 |
| Model Number | 10804-001 |
| Catalog Number | 211890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO SCIENTIFIC |
| Manufacturer Address | DUBUQUE IA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-21 |