MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3955
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Patient Involvement (2645)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.Investigation is pending.
Event or Problem Description
The event involved a chemolock¿ bag spike with additive port, chemolock¿ port, and a 500 ml bag of cytarabine.The nurse hung the bag on an iv pole to start the circle priming process and squeezed the drip chamber.Approximately 10 seconds later, the bag spike dislodged from the bag, and fell to the floor causing chemotherapy to spill from the opening.Chemotherapy proceeded to spill from the now open spout of the bag onto the iv pump, and floor of the med room, and splashed on the shoes and pant hems of the two nurses standing nearby.Both reacted quickly, moving away from the spilling chemo, and one was able to invert the bag to stop the flow.A green kelly clamp was used to pinch the spout closed.The nurses who had chemo splash on their shoes and pants reported that, as far as they could tell, no chemo had directly come in contact with their skin.There was no patient involvement as the device was not taken to the patient, therefore, no patient harm.
Additional Manufacturer Narrative
H10 - one new list# cl3955, chemolock¿ bag spike with additive port, chemolock¿ port.Lot# 3764303 was returned for evaluation.The complaint of disconnection could not be confirmed on the returned chemolock bag spike with additive port.There were no damages or anomalies.As received the set was leak tested.There were no leaks or disconnection noted.The returned bag spike met product design specifications.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history review for lot# 3764303 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK PORT
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10750449
• Report Number: 9617594-2020-00466
• Device Sequence Number: 16938935
• Product Code: ONB
• UDI-Device Identifier: 00887709082502
• UDI-Public: (01)00887709082502(17)230801(10)3764303
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: CL3955
• Device Lot Number: 3764303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 500ML SOLUTION CONTAINER, MFR BAXTER; CYTARABINE, MFR UNK; INFUSION SET, MFR ALARIS