| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | B. BRAUN | ACCESSORIES, PUMP, INFUSION | B. BRAUN MELSUNGEN AG | MRZ | 8713112D | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-12 | 0 |
Patient 1
(B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. THE DEVICE HAS BEEN FORWARDED TO B. BRAUN MELSUNGEN (B)(4) (MANUFACTURER) TO COMPLETE THE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.
Patient 1
THE POWER SUPPLY WAS ORIGINALLY REPORTED AS DAMAGED. ONCE THE POWER SUPPLY WAS RECEIVED BY (B)(4), IT WAS VISUALLY INSPECTED AND IT WAS DISCOVERED THAT THE POWER SUPPLY EXHIBITED SIGNS OF THERMAL DAMAGE.
Patient 1
(B)(4). THE USED POWER SUPPLY WAS RECEIVED FOR EVALUATION, AND DURING THE INITIAL VISUAL EXAMINATION IT WAS DISCOVERED THAT THE POWER SUPPLY EXHIBITED SIGNS OF THERMAL DAMAGE. UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE PINS ON THE PRIMARY ADAPTOR WERE DAMAGED IN A WAY THAT CAUSED THEM TO LOSE CONNECTION WITH THE BOARD INSIDE THE POWER SUPPLY. THE LOOSE CONNECTION BETWEEN THE PINS AND THE INTERNAL BOARD OF THE POWER SUPPLY CAUSED THE THERMAL DAMAGE. BASED ON THE CONDITION OF THE POWER SUPPLY WHEN IT WAS RECEIVED, THE CAUSE OF THE DISCONNECTION WAS MOST LIKELY THE RESULT OF THE POWER SUPPLY BEING DROPPED SEVERAL TIMES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.