MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS PUMP MODULE ADMINISTRATION SET

Model Number 2426-0500

Device Problems Air Leak (1008); Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

The customer reported a spill of etoposide due to a leaking set in which the silicone segment came apart from the safety clamp/lower fitment.Two rns were in the room and the pump was alarming for "air in line".One nurse clamped the tubing below the pump, removed the set from the channel and it popped apart, leaking on the staff and patient.Chemo got onto one nurse's hand and the pt's hand, and sprayed into the other nurse's eye.That nurse went to the er for evaluation.No details of any treatment were provided.There was no pt harm reported or medical intervention required.The customer stated that no additional event or pt info is available.

Manufacturer Narrative

(b)(4).Pt info requested and all available.Unable to determine the cause of the customer's report of leaking.The customer stated the set has been discarded and is not available for failure investigation.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION CORPORATION; san diego CA
• Manufacturer Contact: stephen bilello ; 1020 pacific mesa blvd.; san diego, CA 92121 ; 8586176477
• MDR Report Key: 3700322
• MDR Text Key: 4339163
• Report Number: 9616066-2014-00140
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/28/2014

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 Expiration Date: 11/01/2016
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 13116621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PUMP MODULE, SNS UNK; ALARIS PC UNIT