MAUDE Adverse Event Report: CAREFUSION MAXPLUS® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MP9209

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported that an extension set that was used for an infusion of lipids and d12 at 5.3 ml/hr leaked at the filter.The patient's blood glucose was less than 30 for 4 hours despite d12 boluses, however one hour after changing the filter his blood glucose increased to 127.

Manufacturer Narrative

The customer¿s report of a filter leak was confirmed.Functional testing found that the filter was slightly misaligned within the body and there was a leak between the seams.The root cause of the leak was determined to be light seals on the filter which occurred due to build up on the heat stake during the manufacturing process.

• Brand Name: MAXPLUS® EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5870102
• MDR Text Key: 51921647
• Report Number: 9616066-2016-01057
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: MP9209
• Device Catalogue Number: MP9209
• Device Lot Number: 15086404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 2