MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-09 for IVAC VOLUMETRIC CONTROLLER 280 manufactured by Ivac Medical Systems, Inc..
[15234515]
The pump was received and was visually and functionally tested. Extensive accuracy and rate change testing was performed and no rate change was observed. The pump was found to meet all mfr's specifications. The reported rate change could not be duplicated, however, it is suspected the rate may have been inadvertently altered when pt was entangled in the tubing. Mfr requested pt info, but hospital could not provide it. This report was filled out by the mfr.
Patient Sequence No: 1, Text Type: N, H10
[15684757]
During an infusion, a patient was taking a shower. The nurse came in to check on her and found patinet completely entangled in the iv line. As nurse proceeded to untangle the tubing, nurse noticed pump was no longer infusing at rate of 7cc/hr, but was now set at 110cc/hr. Nurse checked contents of the heparin bag and determined patient had received an overinfusion of 35cc of heparin. There was no resultant patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-1997-00080 |
| MDR Report Key | 91191 |
| Report Source | 05,06 |
| Date Received | 1997-05-09 |
| Date of Event | 1997-04-10 |
| Date Facility Aware | 1997-04-10 |
| Date Mfgr Received | 1997-04-11 |
| Device Manufacturer Date | 1988-08-01 |
| Date Added to Maude | 1997-05-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVAC VOLUMETRIC CONTROLLER |
| Generic Name | CONTROLLER |
| Product Code | LDR |
| Date Received | 1997-05-09 |
| Model Number | 280 |
| Catalog Number | 280 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90092 |
| Manufacturer | IVAC MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10221 WATERIDGE CIRCLE SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-09 |