2C7552S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-05-04 for 2C7552S manufactured by Baxter Healthcare Corporation.

Event Text Entries

[252] Nitroglycerin drip stopped and fluid contionued to flow due to malfunction of roller clamp severe hypotension, was revived with iv fluids and reverse trendelenberg positioning. Patient had no residual effects from adverse event. On examination of the vented nitroglycerin set the roller clamp clearly failed and was the cause of the overdose of iv nitroglycerin to the patient. Manufacturer's quality control division notified and device that caused the adverse event forwarded to manufacturer for further investigation and follow-updevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. 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, performance tests performed, visual examination. Results of evaluation: component failure, other. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 531
• MDR Report Key: 531
• Date Received: 1992-05-04
• Date of Report: 1992-04-17
• Date of Event: 1992-04-12
• Date Facility Aware: 1992-04-12
• Report Date: 1992-04-17
• Date Reported to FDA: 1992-04-17
• Date Reported to Mfgr: 1992-04-15
• Date Added to Maude: 1992-05-08
• 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

Device Details

• Generic Name: VENTED NITROGLYCERIN SET
• Product Code: LLC
• Date Received: 1992-05-04
• Model Number: 2C7552S
• Lot Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 524
• Manufacturer: BAXTER HEALTHCARE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-05-04