MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that during a vasopressor infusion, the tubing was noted to have a tear and leak while the patient was undergoing an mri procedure.The patient's blood pressure decreased temporarily but stabilized with replacement of the tubing.There was no lasting patient harm or medical intervention.Received a copy of the customer's medwatch report from the fda which states, "the nurse discovered fluid coming from out of the infusion pump and, upon examination of the tubing inside the pump, there was a separation in the tubing at the point that it connects with the pump segment.The patient was on a vasopressor medication and there was a period of time, while the nurse was charging the tubing, in which the patient did not receive the medication and experienced a decrease in his blood pressure which returned to normal once the infusion was restarted.This event also occurred in the ct scan suite.".

Manufacturer Narrative

The customer¿s report that the silicone pumping segment tore and leaked was confirmed.Visual inspection of the set showed that the silicone segment was completely separated/torn away from the upper fitment with jagged appearances noted on each corner of the silicone segment.Examination under magnification showed a crush mark to the upper fitment.Functional testing was deemed unnecessary due to the separation.Fluid was observed to be leaking from the set.The root cause of the leak was a separation in the silicone segment.The cause of the separation is unknown.

Manufacturer Narrative

Concomitant medical products: 250ml baxter bag ndc (b)(4), lot number y249599 apr 19 5% dextrose.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The infusion was levophed 8mg/250 ml d5w (32mcg/ml).

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7187801
• MDR Text Key: 97272763
• Report Number: 9616066-2018-00025
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 17083167
• Other Device ID Number: 7613203021012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2017
• 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): Other; Required Intervention
• Patient Age: 66 YR