MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for 03-9202 manufactured by National Medical Care.
[2842]
Heparin line for pump fell off. Pt. Lost blood from line openningdevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: telemetry failure, none or unknown. Conclusion: device failure directly contributed to event, device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4415 |
| MDR Report Key | 4415 |
| Date Received | 1992-07-23 |
| Date of Event | 1992-04-24 |
| Date Facility Aware | 1992-04-24 |
| Date Added to Maude | 1993-05-24 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ARTERIAL BLOOD TUBING |
| Product Code | GIO |
| Date Received | 1992-07-23 |
| Catalog Number | 03-9202 |
| ID Number | RIKO28 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4139 |
| Manufacturer | NATIONAL MEDICAL CARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-23 |