MAUDE Adverse Event Report: ICU MEDICAL, INC. PED TRANSPAC IV KIT

Model Number 46113-75

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 3264170 showed that (b)(4) units were manufactured, tested, inspected and released in june 2016, no exception documents were cited.

Event Description

Complaint received regarding one 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170 (mfd.06/2016).Report states; rn had a uac line that was set up and infusing.Rn tried to get a blood glucose.She turned fluids off to the patient and pulled back on the waste syringe.When slowly pulling back she noticed that she was not getting blood return and her flush syringe had air in it instead, which it had no air to begin with.After trying again and getting the same result she asked another rn to come and look at it.They retraced the lines and made sure the connections were tight.They tried drawing again and the same thing happened.They ended up getting a new uac setup and saved the one that was malfunctioning.No adverse patient consequences reported.

Manufacturer Narrative

Lot review: a review of lot# 3264170 showed that (b)(4) units were manufactured, tested, inspected and released in june 2016, no exception documents were cited.Receipt review: 11/3/2016 - received one used 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170.One used small cannula, one used tubing extension.The tubing extension was added to the squeeze flush.The small cannula was attached to the distal end of the tubing set.The device was flushed and no leaks were observed.Functional testing: unit was pressure tested and leaking was observed from a cracked female luer.Final analysis summary: the reported complaint of air entering the fluid path was confirmed.The root cause of the failure was from a cracked female luer that is consistent with environmental stress.It is unknown the cause of environmental stresses as no use conditions were reported.

Event Description

Complaint received regarding one 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170 (mfd.06/2016).Report states; rn had a uac line that was set up and infusing.Rn tried to get a blood glucose.She turned fluids off to the patient and pulled back on the waste syringe.When slowly pulling back she noticed that she was not getting blood return and her flush syringe had air in it instead, which it had no air to begin with.After trying again and getting the same result, she asked another rn to come and look at it.They retraced the lines and made sure the connections were tight.They tried drawing again and the same thing happened.They ended up getting a new uac setup and saved the one that was malfunctioning.No adverse patient consequences reported.

• Brand Name: PED TRANSPAC IV KIT
• Type of Device: PED TRANSPAC IV KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 6106903
• MDR Text Key: 60074889
• Report Number: 2025816-2016-00227
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/01/2019
• Device Model Number: 46113-75
• Device Catalogue Number: 46113-75
• Device Lot Number: 3264170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA