MAUDE Adverse Event Report: ICU MEDICAL CHEMOLOCK; INTRAVASCULAR ADMINSTRATION SET

Model Number	CL3534
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: two suspect lots were reported: lot # 3436827 (mfg date 5/2017) shows (b)(4) units and lot # 3432850 (mfg date 4/2017) shows (b)(4) units were manufactured, tested, inspected, and released with no exception documents cited.
Event or Problem Description
Chemolock adapter used as part of baxter iv administration set for circle priming and administration of chemotherapy.Chemotherapy infusion was discovered to be leaking, specifically the chemotherapy adapter, approximately 5 minutes into chemotherapy infusion.Product reached patient, no apparent harm.
Additional Manufacturer Narrative
Lot review: two suspect lots were reported: lot # 3436827 (mfg date 5/2017) shows (b)(4) units and lot # 3432850 (mfg date 4/2017) shows (b)(4) units were manufactured, tested, inspected, and released with no exception documents cited.Visual analysis: cl3534 was received with mating device and found to be leaking at chemolock.Functional analysis: returned cl3534 was pressure tested.Leakage was detected at the chemolock spin mechanism.The o-ring was found to be misassembled on the post.Summary: the cl3534 was confirmed to be leaking.The cause was a mis-assembled o-ring.
Event or Problem Description
Chemolock adapter used as part of baxter iv administration set for circle priming and administration of chemotherapy.Chemotherapy infusion was discovered to be leaking, specifically the chemotherapy adapter, approximately 5 minutes into chemotherapy infusion.Product reached patient, no apparent harm.

• Brand Name: CHEMOLOCK
• Common Device Name: INTRAVASCULAR ADMINSTRATION SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 6708918
• Report Number: 2025816-2017-00163
• Device Sequence Number: 1540361
• Product Code: ONB
• UDI-Device Identifier: 00887709057067
• UDI-Public: 887709057067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: CL3534
• Device Catalogue Number: CL3534
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1