MAUDE Adverse Event Report: ICU MEDICAL, INC. 0.2 MICRON FILTER

Model Number B6008

Device Problem Filter leak(s) (1237)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

Complaint received reporting (filter) leakage issue with use of one b6008 0.2 micron filter.The b6008 device was pre-tested/primed prior to placement with no issues noted at that time.The device was initially placed on (b)(6) 2014, one infusion of etoposide (131 mg/700 ml) running at 29ml/hr for 24 hour duration was administered without incident.The b6008 device was removed, replaced and discarded.There were no injuries or adverse consequences to the clinicians, patient or family members that were present.

Manufacturer Narrative

Investigation: a review of the mfg.Lot build database for the reported lot# 28068024 (mfg.Date 01/2014) shows (b)(4) units were mfg.Tested, inspected and released.There were no exception documents generated during the lot build.Conclusion: the involved b6008 device was not returned for analysis and confirmation.The exact cause(s) of the reported event are unknown at this time.

• Brand Name: 0.2 MICRON FILTER
• Type of Device: 0.2 MICRON FILTER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4437876
• MDR Text Key: 5388462
• Report Number: 2025816-2014-00149
• 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: Other
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B6008
• Device Catalogue Number: B6008
• Device Lot Number: 2806802
• Other Device ID Number: PR# 27697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: SPIROS CONNECTOR; MICROCLAVE CONNECTOR; NOI
• Patient Age: 19 MO