MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE EXT. SET W/0.2 MICRON FILTER; MICROCLAVE FILTERED EXT SET

Model Number MC33382

Device Problem Filter leak(s) (1237)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Complaint received concerning leakage incident with use of one mc33382 15" microclave ext.Set w/0.2 micron filter.It was reported mc33382 sets ".Filter leaked after three (3) 1 hour intermittent etoposide infusions following a doxorubicin and vincristine infusion." the mc3382 device was removed, replaced and discarded.Follow up information received reports the device set was pre-tested /primed and placed on 10/11 with no issues noted at that time.The mc33382 device set had been infusing for 73 hrs prior to the leak.The leakage was identified by the family.The family had moved the tubing , when they were putting the child into bed, and noticed that it was wet.The rn was notified.The tubing was changed out.Limited to no direct chemotherapy exposure occurred to the patient, family, and rn, as iv fluids were running post vp-16.There was no harm to patient, family members or clinicians.

Manufacturer Narrative

Conclusion: the involved mc33382 device was not returned for analysis and confirmation.The exact cause(s) of the reported event are unknown at this time.

• Brand Name: MICROCLAVE EXT. SET W/0.2 MICRON FILTER
• Type of Device: MICROCLAVE FILTERED EXT SET
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4479855
• MDR Text Key: 5570047
• Report Number: 2025816-2014-00226
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33382
• Device Catalogue Number: MC33382
• Other Device ID Number: PR# 28027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/14/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 2 YR