MAUDE Adverse Event Report: ICU MEDICAL CHEMOCLAVE; ADMIN SET

Model Number	CH-12
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported lot 3002746 shows (b)(4) units were manufactured and released with no exception documents cited.
Event or Problem Description
Possible ch-12 "dry spike" product failure.The dry spike appears to have shed plastic from the spike into the line.The plastic did not reach the patient.No patient involvement.
Additional Manufacturer Narrative
Reported lot 3002746 shows 1,800 units were manufactured and released with no exception documents cited.Visual: particulates were observed in the lumen.Functional: particles of dry spike adapter diaphragm shed were found in the drip chamber.Particles of dry spike adapter diaphragm shed were found in the iv line.Summary analysis: the complaint of material being shed into the fluid path was confirmed.The issue appears to be related to a usage technique that promotes dry spike diaphragm shedding during use.
Event or Problem Description
Possible ch-12 "dry spike" product failure.The dry spike appears to have shed plastic from the spike into the line.The plastic did not reach the patient.No patient involvement.

• Brand Name: CHEMOCLAVE
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 6712665
• Report Number: 2025816-2017-00179
• Device Sequence Number: 16535632
• Product Code: FPA
• UDI-Device Identifier: 00840619023713
• UDI-Public: 840619023713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: Pharmacist
• Device Expiration Date: 02/01/2020
• Device Model Number: CH-12
• Device Catalogue Number: CH-12
• Device Lot Number: 3002746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1