MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-09-24 for SAFETY DRAIN manufactured by .
[185111]
In 1999 a cardiopulmonary tech was attempting to suction condensate from a safety drain that was connected to a bear iii ventilator. The pt was a 49-yr-old male with end stage renal disease. The safety drain was placed between the main expiratory valve midway in the circuit and the one way check valve that connects on top of the flow sensor tube. This one way valve normally remains closed except when the pt is exhaling. The directions for use for this mfr's device indicate that the vacuum system should be set at 120mmhg to 140mmhg when emptying the circuit drain. Hosp personnel reported that the vacuum setting was at "full vacuum" which can be several times higher than the recommended amount. It is conceivable that a negative pressure could be created when the suction probe is inserted into the suction port of the safety drain. The exhalation valve can close if suction continues after the safety drain between two closed valves, a vacuum lock can be created and the pt may not be able to exhale. A chest x-ray revealed a pneumothorax that required the insertion of a chest tube. Two days later the pt died. The cause of death was end stage renal disease. Hosp personnel stated that the pneumothorax did not cause or contribute to the pt's death. The facility does not feel that the device failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719891-1999-00015 |
| MDR Report Key | 242079 |
| Report Source | 00 |
| Date Received | 1999-09-24 |
| Date of Report | 1999-09-24 |
| Date of Event | 1999-07-19 |
| Date Mfgr Received | 1999-08-27 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 1999-09-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | E. CHAMBERLAIN, PHD |
| Manufacturer Street | 12050 LONE PEAK PKWY |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8015726800 |
| Manufacturer G1 | BALLARD MED PRODUCTS |
| Manufacturer Street | 1999 ALVIN RICKEN DR |
| Manufacturer City | POCATELLO ID 83201 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 83201 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY DRAIN |
| Generic Name | CLOSED CIRCUIT DRAIN |
| Product Code | BYH |
| Date Received | 1999-09-24 |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 227327 |
| Baseline Brand Name | SAFETY DRAIN |
| Baseline Generic Name | CLOSED CIRCUIT DRAIN |
| Baseline Model No | NA |
| Baseline Catalog No | 132 |
| Baseline ID | NA |
| Baseline Device Family | CLOSED CIRCUIT DRAIN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K881790 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1999-09-24 |