MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOLOCK BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CLH-12

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

Situation: due to a chemo bag leak, a patient receiving chemo had to wait until a new bag could be made and delivered.Background: chemotherapy bag started leaking after the bag adapter fell out during tubing priming.Assessment: the chemo was made using a 100ml ns bag with a chemolock bag adapter.After the bag was spiked with the tubing, the nurse stepped away and saw that the adapter had fallen out of the bag and the chemotherapy spilled on the floor.When the bag was returned to the pharmacy, the bag and the adaptor had a pretty good connection but the weight of the adapter and the tubing hanging off the side of the table could have contributed to the adapter falling out.Recommendation: investigate other adapters available in the market.

• Brand Name: CHEMOLOCK BAG SPIKE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10471155
• MDR Text Key: 204914780
• Report Number: 10471155
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/19/2020

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
• Device Operator: No Information
• Device Model Number: CLH-12
• Device Catalogue Number: CLH-12
• Device Lot Number: 4173583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7665 DA
• Patient Weight: 48