MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-02 for CENTRAL VENOUS PRESSURE MONITOR 4338A manufactured by Edwards Div., Baxter Healthcare Coorp..
[16619404]
Above the last port of cvp tubing, a possible air leak causes air to enter tubing and iv fluid to leak. This happened 2 times with same lot number. Potential air to the pt. (different lot # than reported on 2/23/95).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005278 |
| MDR Report Key | 20035 |
| Date Received | 1995-02-28 |
| Date of Report | 1995-02-28 |
| Date of Event | 1995-02-28 |
| Date Added to Maude | 1995-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRAL VENOUS PRESSURE MONITOR |
| Generic Name | MONITOR |
| Product Code | KRK |
| Date Received | 1995-03-02 |
| Catalog Number | 4338A |
| Lot Number | Y4L164, Y4H063 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19929 |
| Manufacturer | EDWARDS DIV., BAXTER HEALTHCARE COORP. |
| Manufacturer Address | VALENCIA CA 91355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-28 |