MAUDE Adverse Event Report: ICU MEDICAL INC. 15" DROP ADMIN SET

Model Number 061-CH3062

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned.The initial reporter stated that the chemo bag was stored in the refrigerator on shelves lying flat.The bags are spiked as they are preparing them for infusion at the patient's bedside.A two year review of complaints database revealed no additional reports for 061-ch3062/similar problem.

Event Description

Chemo was noted to be bubbling out through the air vent port at the top of the drip chamber.Patient was receiving bendamustine.Infusion was not completed therefore the set was replaced to continue treatment.No adverse patient consequences were reported.

Manufacturer Narrative

Device return: one (1) used 061-ch3062; one empty freeflex 500ml 0.9% nacl bag; one unidentified used bifurcated tubing set w/ spikes, pinch clamps.Visual inspection (pre and post decontamination) of the "as-received" 061-ch3062 device set and the remaining used mating devices was performed.During decontamination flushing of the used 061-ch3062 device set decontamination fluid was observed originating from the sets filter vent on the drip chamber.There were no other anomalies noted.Engineering testing and analysis of the returned 061-ch3062 and returned mating device(s) were pressure leak tested per applicable product specifications.The results recorded leakage originating from the 061-ch3062 sets filter vent.The filter vent was removed and examined.The engineers report documents the filter vent was damaged.The characteristics of the filter vent component damages were consistent with excessive and or prolonged chemical/alcohol exposures.

Event Description

Int'l.((b)(6)) complaint received reporting leakage issues with use of two (2) 061-ch3062 41" 15 drop admin set w/rotating luer, lot # unknown.The initial information received describes one event on 07/04 where after a unspecified time during infusion ".Chemo was noted to be bubbling out through the (061-ch3062 sets) air vent port at the top of the drip chamber.Set (was removed) and replaced with a new set to continue treatment.".It was also reported that a similar incident occurred "a few months ago.Chemo bubbling out from the air vent." attending clinician reportedly came into contact with the unspecified chemo and was examined per hospital protocol, no reported treatments required as a result.The involved 061-ch3062 device set was removed, replaced and discarded.There were no reported injuries/adverse consequences to the involved patients or clinicians.Follow up information: the chemo set-ups were prepared offsite ((b)(6) pharmacy) transported to hospital unit where they were "stored in.Fridge on shelves lying flat".The set-ups are than delivered this is the mfgers.Follow up report to provide corrected / additional information and device return investigation findings.

• Brand Name: 15" DROP ADMIN SET
• Type of Device: ADMIN SET
• 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 ; 8012641702
• MDR Report Key: 6762008
• MDR Text Key: 82764228
• Report Number: 2025816-2017-00161
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619068202
• UDI-Public: 840619068202
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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
• Device Operator: Health Professional
• Device Model Number: 061-CH3062
• Device Catalogue Number: 061-CH3062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 07/04/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1