MAUDE Adverse Event Report: CARE FUSION CORP. ALARIS IV TUBING; ALARIS PUMP PRIMARY IV TUBING

Model Number SET NO. 72023E

Device Problems Break (1069); Failure to Disconnect (2541); Insufficient Information (3190)

Patient Problems Death (1802); No Information (3190)

Event Date 07/22/2015

Event Type  Injury  

Event Description

Iv tube broke while disconnecting patient from primary iv tubing for alaris pumps, leaving end piece stuck inside microlave.

• Brand Name: ALARIS IV TUBING
• Type of Device: ALARIS PUMP PRIMARY IV TUBING
• Manufacturer (Section D): CARE FUSION CORP.; 3750 torrey view ct.; san diego CA 92130
• MDR Report Key: 4994707
• MDR Text Key: 22876866
• Report Number: 4994707
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SET NO. 72023E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Distributor Facility Aware Date: 07/22/2015
• Date Report to Manufacturer: 07/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR