MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC MONITORING KIT; SAFESET MONITORING KIT

Lot Number 3327313

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

Arterial line safeset syringe plunger came apart and was non-functional.Black robber stopper was detached from syringe.Blood was backed up in the syringe and unsure if air was present.Safeset changed.No harm to pt.Also noted in other safesets that the rubber sleeve inside the syringe detached from its anchor point.

• Brand Name: TRANSPAC MONITORING KIT
• Type of Device: SAFESET MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL; san clemente CA 92673
• MDR Report Key: 6063184
• MDR Text Key: 58758713
• Report Number: MW5065653
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Lot Number: 3327313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR