SAFETY DRAIN 132

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-09-28 for SAFETY DRAIN 132 manufactured by .

Event Text Entries

[159350] On 7/22/99, a cardiopulmonary tech was attempting to suction condensate from a safety drain that was connected to a ventilator. The pt was a 58-year-old male with severe respiratory problems. 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 setting should be set at 120mmhg to 140mmhg when emptying the circuit drain. Hospital 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 is emptied. With negative pressure in the safety drain between two close valves, a vacuum lock can be created and the pt may not be able to exhale. In this incident, the pt's blood pressure and heart rate decreased. The pt was immediately disconnected from the ventilator and manually "bagged. " there was no pt injury. Once the safety drain cup was disconnected, pressure was released from the expiratory valve and the one way check valve. The pt was reconnected to the ventilator and no further problems occurred. Proper vacuum setting may have prevented this incident. Also, product labeling for this mfr's device indicates that "caution should be used when drain is placed between the output of exhalation valve and a spirometer with a one-way valve which closes to atmosphere. " ballard has contacted ventilator mfr to inform them of this incident and a copy of this report will be forwarded to their regulatory affairs department.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1719891-1999-00016
• MDR Report Key: 243075
• Report Source: 00
• Date Received: 1999-09-28
• Date of Report: 1999-09-28
• Date of Event: 1999-07-22
• Date Mfgr Received: 1999-08-27
• Device Manufacturer Date: 1999-05-01
• Date Added to Maude: 1999-10-06
• 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, PH.D.
• Manufacturer Street: 12050 LONE PEAK PKWY
• Manufacturer City: DRAPER UT 84020
• Manufacturer Country: US
• Manufacturer Postal: 84020
• Manufacturer Phone: 8015726800
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SAFETY DRAIN
• Generic Name: CLOSED CIRCUIT DRAIN
• Product Code: BYH
• Date Received: 1999-09-28
• Model Number: NA
• Catalog Number: 132
• Lot Number: 65219
• 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: 227322
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-09-28