MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-14 for VOLUMETRIC INFUSION CONTROLLER 262+ manufactured by Ivac Medical Systems.
[7761134]
Mfr's report date 12/05/97. The pump was visually and functionally tested. The inspection seal was broken. Rate accuracy was performed and found to meet mfr's specs. Add'l investigation revealed that the alignment of the pincher and anvil was within tolerance, however, the pincher gap was out of spec. Engineering determined this issue to be a random occurrence. It is suspected that the gap could have contributed to the incident but no performance issues were experienced during the eval. We were unable to duplicate the reported overinfusion. The instrument was routed through svc updates and repair and met all mfr's spec prior to return to the user. We will monitor for this issue.
Patient Sequence No: 1, Text Type: N, H10
[16027023]
It was reported that an overinfusion of medication occurred with a pt. There was no resultant pt complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-1997-00108 |
| MDR Report Key | 106947 |
| Report Source | 05 |
| Date Received | 1997-07-14 |
| Date of Event | 1997-06-01 |
| Date Mfgr Received | 1997-06-19 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 1997-07-23 |
| 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 | VOLUMETRIC INFUSION CONTROLLER |
| Generic Name | CONTROLLER |
| Product Code | LDR |
| Date Received | 1997-07-14 |
| Model Number | 262+ |
| Catalog Number | 262+ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 105120 |
| Manufacturer | IVAC MEDICAL SYSTEMS |
| Manufacturer Address | 10221 WATERIDGE CIRCLE SAN DIEGO CA 92121 US |
| Baseline Brand Name | VOLUMETRIC INFUSION CONTROLLER |
| Baseline Generic Name | INFUSION CONTROLLER |
| Baseline Model No | 262+ |
| Baseline Catalog No | 262+ |
| Baseline ID | NA |
| Baseline Device Family | INFUSION CONTROLLER |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K894487 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-14 |