MAUDE Adverse Event Report: ICU MEDICAL, INC. SETSOURCE SMILLBORE PRESSURE INFUSION EXT. SET; SMLLBORE PRESSURE INFUSION EXT. SET

Model Number Z2017

Device Problem Connection error (1116)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

Complaint received reporting attachment/leakage issues with use of z2017 8" smllbore pressure infusion sets w/remy microclaves.It was reported that during the week of (b)(6)".The er sent three patients to the icu with this set and the icu found the removable clave loose and leaking blood.".There was no reported adverse patient consequences.The manufacturer has requested additional information as well as the status/availability of the involved devices and or same lot sample devices.There has been no response as of the date of this report.

Manufacturer Narrative

Manufacturer's investigation: a review of the mfg.Lot build database for the reported lot# 35-005-sj (mfg.11/2013) showed (b)(4) units and lot #35-841-jw (mfg.Date 11/2013) showed (b)(4) units were all mfg., tested, inspected and released.There were no exception documents generated.A review of the complaint database for this list#/similar issue recorded no additional reports.The mfr's complaint team reviewed the reported incident/product issues.Monthly mgmt review of in-process assembly/quality trend reports identified no adverse trends or contributing issues for the applicable components/sub assy builds.Conclusion: the involved device(s) were not returned for analysis and investigation.The cause of the reported incident/product issue is unknown.

• Brand Name: SETSOURCE SMILLBORE PRESSURE INFUSION EXT. SET
• Type of Device: SMLLBORE PRESSURE INFUSION EXT. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3807656
• MDR Text Key: 19973764
• Report Number: 2025816-2014-00008
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z2017
• Device Catalogue Number: Z2017
• Device Lot Number: 35-005-SJ;35-841-JW
• Other Device ID Number: PR# 23136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2013
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN MATING/ACCESS DEVICES,