MAUDE Adverse Event Report: ICU MEDICAL, INC SETSOURCE 7 " PRESSURE INFUSION EXT SET; IV PRESSURE INFUSION EXT SET

Catalog Number Z2199

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

The high pressure tubing extension did not fasten securely, causing it to leak even after tightening and redressing.The patient needed this to be secure as he was getting infusion dye from ct.New tubing applied and no further issues.

• Brand Name: SETSOURCE 7 " PRESSURE INFUSION EXT SET
• Type of Device: IV PRESSURE INFUSION EXT SET
• Manufacturer (Section D): ICU MEDICAL, INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8195473
• MDR Text Key: 131379650
• Report Number: 8195473
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z2199
• Device Lot Number: 3863834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8760 DA