MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-28 for NAVICARE NURSE CALL NNC 3.2.302 manufactured by Hill-rom Cary.
[58714652]
The patient received an over dosage of heparin. Staff intervened with additional medicine and the patient recovered with no adverse outcome. Heparin is used to treat and prevent blood clots in the veins, arteries, or lung. It is also used before surgery to reduce the risk of blood clots. Bleeding is the chief sign of heparin over dosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding. Immediate treatment to reduce heparin's effect must be administered. Hill-rom's investigation determined the previous patient's weight was sent for the current patient. Analysis of the (b)(6) nurse call's log files found that for the room in question, the bed weight was not zeroed and a new weight was not captured prior to the patient being admitted into the nnc system. Additionally, the site's configuration was for the bed data, which includes the weight, to refresh immediately on patient admission. This configuration setting was modified so that the bed data will not refresh on admit. This was tested and confirmed to operate as desired with the customer. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[58714653]
Hill-rom received a report from the account stating an incorrect patient weight was transferred to a patient's emr and based on that weight, the wrong dosage of blood thinning medication was administered to the patient. The nurse call system was located at the account. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027454-2016-00001 |
| MDR Report Key | 6064714 |
| Date Received | 2016-10-28 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-09-28 |
| Device Manufacturer Date | 2014-07-11 |
| Date Added to Maude | 2016-10-28 |
| 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 | MR. GEOFF GORHAM |
| Manufacturer Street | 1225 CRESCENT GREEN DR., SUITE 300 |
| Manufacturer City | CARY NC 27518 |
| Manufacturer Country | US |
| Manufacturer Postal | 27518 |
| Manufacturer Phone | 9198533427 |
| Manufacturer G1 | HILL-ROM |
| Manufacturer Street | 1225 CRESCENT GREEN DR., SUITE |
| Manufacturer City | CARY NC 27518 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27518 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NAVICARE NURSE CALL |
| Generic Name | NAVICARE NURSE CALL |
| Product Code | ILQ |
| Date Received | 2016-10-28 |
| Model Number | NNC 3.2.302 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM CARY |
| Manufacturer Address | 1225 CRESCENT GREEN DR., SUITE 300 CARY NC 27518 US 27518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-28 |