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

Model Number 42646-06

Device Problem Decoupling (1145)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 3327313 showed that (b)(4) were manufactured, tested, inspected and released, citing no exception documents in august 2016.

Event Description

Complaint received, via mw 5065653 regarding one 42646-06 transpac iv monitoring kit, lot# 3327313 ((b)(4)).Report states; arterial line safeset syringe plunger came apart and was not-functional.Black rubber stopper was detached from syringe.Blood was backed up in the syringe and unsure if air was present.Safeset change.No harm to pt.Also noted in other safesets that the rubber sleeve inside the syringe detached from its anchor point.No adverse patient consequences reported.

Manufacturer Narrative

Lot review: a review of lot# 3327313 sowed that (b(4) were manufactured, tested, inspected and released, citing no exception documents in august 2016.Visual inspection: received (1) used 42646-06 transpac iv monitoring kit, reported lot# 3327313.The admin part of the set was not returned.The set was returned with a 10ml bd empty 0.9% sodium chloride syringe attached to the squeeze flush female luer port.Blood observed in the zeroing stopcock.Functional/performance testing: unit was leak tested and no leaking was observed anywhere in the set.The rubber sleeve inside the syringe was not observed to have detached from its anchor point.Using a black light, uv adhesive was observed on each of the bonding tips for the clips of the syringe plunger and the clip engagement on the shaft of the syringe.The clips were observed to not have been clipped into the clip engagement.Final analysis summary: the reported complaint of plunger tip separation was confirmed.The root cause of the failure was from the clips not fully inserted into the mating component.Manufacturing and quality have been notified for their heightened awareness and re-training has been completed by the manufacturing operators.Additionally changes have been made to the process to improve manufacturing.Icu medical will monitor and trend.

Event Description

Complaint received, via mw5065653, report states; arterial line safeset syringe plunger came apart and was not-functional.Black rubber stopper was detached from syringe.Blood was backed up in the syringe and unsure if air was present.Safeset change.No harm to pt.Also noted in other safesets that the rubber sleeve inside the syringe detached from its anchor point.No adverse patient consequences reported.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: TRANSPAC IV MONITORING 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: 6152751
• MDR Text Key: 61749122
• Report Number: 2025816-2016-00262
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/01/2019
• Device Model Number: 42646-06
• Device Catalogue Number: 42646-06
• Device Lot Number: 3327313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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