MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-04 for BALLARD CLOSED CIRCUIT DRAIN, PROBE AND Y ADAPTER 132 manufactured by Ballard Medical Products.
[126431]
Pt became bradycardic and hypotensive after closed circuit drain was suctioned. Was unsure what caused the incident. It happened again on 7/17/99 at 0145. Still unsure what caused the incident. Ventilator and circuit were changed after second incident. After similar incident occurred on another pt on 7/22/99, it is speculated that the cause of the three incidents is the same. When the water is suctioned from the closed circuit drain, the negative pressure causes the passive exhalation diaphragm to stick. The pt cannot exhale. The lungs over expand causing cardiac tamponade with subsequent bradycardia and hypotension.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016858 |
| MDR Report Key | 234553 |
| Date Received | 1999-08-04 |
| Date of Report | 1999-07-29 |
| Date of Event | 1999-07-16 |
| Date Added to Maude | 1999-08-06 |
| 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 |
| 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 | BALLARD CLOSED CIRCUIT DRAIN, PROBE AND Y ADAPTER |
| Generic Name | CLOSED CIRCUIT DRAIN, PROBE AND Y ADAPTER |
| Product Code | BYH |
| Date Received | 1999-08-04 |
| Model Number | NA |
| Catalog Number | 132 |
| Lot Number | 65219 |
| ID Number | 4867153 (PATENTS) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227327 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | 12050 LONE PEAK PKWY DRAPER UT 84020 US |
| 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. Life Threatening | 1999-08-04 |