MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2003-01-14 for COLLEAGUE VOLUMETRIC INFUSION PUMP 2M8151 manufactured by Baxter Healthcare (sg).
[36413760]
The pump has not been received. Should the pump become available for eval, a f/u report will be filed upon completion of an eval or if any add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
[36413761]
The facility's tech reported an infusion pump with a 812:02 failure code that was found during biomed testing. The tech stated that there has been no reports of any patient incident involving this pump since the last baxter service event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000001-2003-00427 |
| MDR Report Key | 5336027 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2003-01-14 |
| Date of Report | 2003-01-07 |
| Date of Event | 2003-01-01 |
| Date Mfgr Received | 2003-01-07 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 2015-12-30 |
| 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 | 3 |
| Manufacturer Contact | JOANNE CELBA |
| Manufacturer Street | RTE 120 AND WILSON RD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704696 |
| Manufacturer G1 | BAXTER HEALTHCARE (SG) |
| Manufacturer Street | 2 WOODLANDS INDUST PARK D |
| Manufacturer City | SINGAPORE 738750 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 738750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLLEAGUE VOLUMETRIC INFUSION PUMP |
| Generic Name | INFUSION PUMP |
| Product Code | DRN |
| Date Received | 2003-01-14 |
| Model Number | COLLEAGUE |
| Catalog Number | 2M8151 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE (SG) |
| Manufacturer Address | 2 WOODLANDS INDUSTRIAL PARK D SINGAPORE 738750 SN 738750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-01-14 |