MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for SIGMA SPECTRUM INFUSION PUMP 35700BAX2 manufactured by Baxter Healthcare Corporation.
[72689669]
Patient Sequence No: 1, Text Type: N, H10
[72689670]
Mini-bags of iv antibiotics infused via an iv pump found with remaining volume following the infusion requiring the nurse to reset the pump to ensure full volume of the medication is infused - unclear if bags are overfilled from the manufacturer or if there is a possible pump operation issue. Upon investigation we found that the nurse programmed the pump to infuse a 100cc bag at a rate of 100cc/hr. At the end of the hour there was still fluid left in the iv bag greater than 10cc. It is not known if there was an issue with the bag or the pump at the time of the infusion. According to pharmacy services there is there may be an overfill of 10% or 10cc. However, that remained was greater than 10cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6489518 |
| MDR Report Key | 6489518 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-02-15 |
| Report Date | 2017-04-07 |
| Date Reported to FDA | 2017-04-07 |
| Date Reported to Mfgr | 2017-04-07 |
| Date Added to Maude | 2017-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGMA SPECTRUM INFUSION PUMP |
| Generic Name | INFUSION SAFETY MANAGEMENT SOFTWARE |
| Product Code | PHC |
| Date Received | 2017-04-13 |
| Model Number | 35700BAX2 |
| Catalog Number | 35700BAX2 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 7511 114TH AVENUE NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |