MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-12-09 for PLUNGER HOLDER/TRACK II NA manufactured by Medex.
[15487423]
During in-house testing, the hex value was not greater than c0 on a plunger holder/track ii, which would have caused the syringe pump to fail to alert "load syringe plunger" or "occlusion' depending on the pump's software.
Patient Sequence No: 1, Text Type: D, B5
[15574291]
During in-house testing, the hex value was not greater than c0 on the track, which would have caused a syringe pump to fail to alert "load syringe plunger" or "occlusion" depending on the pump's software. This was due to a nonfunctional dome switch on the long flex cable. Medex was able to confirm the issue and determine a cause. The plunger holder/track ii was repaired and returned to the customer. No add'l action is necessary at this time. Medex considers this mdr closed with this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036813-2004-00092 |
| MDR Report Key | 798280 |
| Report Source | 07 |
| Date Received | 2004-12-09 |
| Date of Report | 2004-11-09 |
| Date of Event | 2004-11-09 |
| Date Mfgr Received | 2004-11-09 |
| Date Added to Maude | 2006-12-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS RD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX |
| Manufacturer Street | 4350 RIVER GREEN PKWY, STE 200 |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30096 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUNGER HOLDER/TRACK II |
| Generic Name | PLUNGER HOLDER/TRACK II |
| Product Code | FIH |
| Date Received | 2004-12-09 |
| Model Number | PLUNGER HOLDER/TRA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 785813 |
| Manufacturer | MEDEX |
| Manufacturer Address | * DULUTH GA 30096 US |
| Baseline Brand Name | PLUNGER HOLDER/TRACK II |
| Baseline Generic Name | PLUNGER HOLDER/TRACK II |
| Baseline Model No | PLUNGER HOLDER/ |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-09 |