HI-FLO TRAUMA (TM) BIFURCATED SET MX 882

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 HI-FLO TRAUMA (TM) BIFURCATED SET MX 882 manufactured by Medex,inc.

Event Text Entries

[250] 52 year old male patient sustained multiple injuries in a motor vehicle accident and was found pinned in the wreckage. On assessment by lifeflight staff he had difficult and occasional agonal respirations, no bp by cuff through carotid pulse palpable. Ems had been unable to place iv lines. When patient extricated, he was bagged, nasopharyngeal tube placed, masts placed, and cpr begun. On helicopter, moniitor placed, patient to asystole. Initial iv access was lost when side port in the trauma tubing failed when the clamp was released, diverting iv fluid out the port. On replacement, the second tubing also failed, the tubing twisted under pressure and iv access couldn't be re-established. The patient expired after arrival at the e. Rdevice not labeled for single use. Patient medical status prior to event: invalid data. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 522
• MDR Report Key: 522
• Date Received: 1992-05-04
• Date of Report: 1992-04-17
• Date of Event: 1992-03-06
• Date Facility Aware: 1992-03-06
• Report Date: 1992-04-17
• Date Reported to FDA: 1992-04-17
• Date Reported to Mfgr: 1992-03-23
• Date Added to Maude: 1992-05-07
• 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: HI-FLO TRAUMA (TM) BIFURCATED SET
• Generic Name: TRAUMA TUBING
• Product Code: FIG
• Date Received: 1992-05-04
• Model Number: MX 882
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 515
• Manufacturer: MEDEX,INC

Patients

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