3M ARTHROSCOPIC DRAINAGE PUMP 83000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-02 for 3M ARTHROSCOPIC DRAINAGE PUMP 83000 manufactured by 3m Arthroscopic Drainage Pump.

Event Text Entries

[16365486] During arthroscopic surgery for probable left knee medical meniscue and anterior cruciate ligament tears, the physician noticed patient's thigh tight. He then stopped the irrigation and disconnected the pump due to improper drainage and extravosation into thigh and leg. Pressures were measured at 68mm thigh and leg dropping to 48mm within 20 minutes. Arthroscopiy irrigation 2300 cc in/600 cis out plus spillage. Pedal pulses were present. Thigh circum. Rt 19 3/4" lt 21". Procedure was aborted. Patient and family were informed about this event. He was discharged home after observation in pacudevice not labeled for single use. Patient medical status prior to event: satisfactory 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. Results of evaluation: invalid data. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service, user education provided. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1280
• MDR Report Key: 1280
• Date Received: 1992-07-02
• Date of Report: 1992-05-19
• Date of Event: 1992-04-10
• Date Facility Aware: 1992-04-10
• Report Date: 1992-05-19
• Date Reported to FDA: 1992-05-19
• Date Reported to Mfgr: 1992-04-10
• Date Added to Maude: 1992-09-14
• 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

• Brand Name: 3M ARTHROSCOPIC DRAINAGE PUMP
• Generic Name: 3M ARTHROSCOPIC DRAINAGE PUMP
• Product Code: FHF
• Date Received: 1992-07-02
• Model Number: 83000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1226
• Manufacturer: 3M ARTHROSCOPIC DRAINAGE PUMP

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-02