MAUDE Adverse Event Report: ICU MEDICAL INC. NICU SAFESET W/TP4 SQUEEZE FLUSH; NEEDLELESS VALVE MTG. KIT

Model Number 46101-98

Device Problems Leak/Splash (1354); Output Problem (3005)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

Pending receipt of device.

Event Description

Complaint received reporting air in lines with use of 46101-98 nicu safeset w/tp4 squeeze flush; needleless valve mtg.Kit.The initial information received reports there have been three incidents where ".Air is entering the line after the kit is properly primed and while on a patient.The issues were detected with loss of / dampened waveforms, monitor alarmed and visually.This was noted mostly in and around the transducer.".The devices were removed and replaced.There were no reported adverse patient consequences.Additional event/device information was requested but as of the date of this report no responses have been received.

Manufacturer Narrative

Device return: two (2) packaged 46101-98 nicu safeset mtg.Kit; lot# 3396971 and one packaged mating device baxter clearlink continu-flo set with duo-vent spike, model 2c8551 s.Engineering testing and analysis: the returned packaged 46101-98 mtg kit same lot samples were each tested to the applicable product specifications which includes leak, vacuum and restriction testing.The results recorded no performance issue(s) and or out of spec conditions.Additional testing: each of the 46101-98 mtg.Kits were connected to the returned baxter clearlink set and functionally tested including pressure and vacuum testing.The results recorded no leakages, no performance and or functional issues.The set-ups met the acceptance criteria.Findings: testing and analysis of the two returned 46101-98 mtg.Kit packaged same lot samples recorded no functional and or out of spec conditions.The mfger.Was unable to replicate or confirm the reported product issue with the unused same lot samples.At this time, the exact cause(s) of the product issue is unknown.The mfger.Will continue to monitor and trend these types of reported product issues and initiate preventative measures as applicable.

Event Description

Complaint received reporting complaint received reporting air in lines with use of 46101-98 nicu safeset mtg.Kit, lot# 3396971.The information received reports there have been three incidents where ".Air is entering the line.".This was detected visually and when loss of and/or dampened waveforms occurred and monitor alarms.The devices were removed and replaced.There were no reported adverse patient consequences.This is the mfgers.Follow up report to provide additional information and device return investigation findings.

• Brand Name: NICU SAFESET W/TP4 SQUEEZE FLUSH; NEEDLELESS VALVE MTG. KIT
• Type of Device: NICU SAFESET W/TP4 SQUEEZE FLUSH; NEEDLELESS VALVE MTG. 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: terry scesny ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6620255
• MDR Text Key: 77297761
• Report Number: 2025816-2017-00115
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 46101-98
• Device Catalogue Number: 46101-98
• Device Lot Number: 3396971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1