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

Model Number 2426-0500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 03/15/2016

Event Type  Death  

Manufacturer Narrative

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 customer reported a pump segment leak near the upper fitment during a fentanyl infusion, dosage and rate unknown.The infusion was noted to be empty 2 hours after initiation with approximately 100ml of medication found on the floor.Although the patient was gravely ill with multiple comorbidities and passed away 5 days later, the customer does not report any patient harm from this event and does not attribute the patient's demise to the event.

Manufacturer Narrative

The customer¿s report of the set leaking was confirmed.Visual inspection of the set showed that the silicone segment had a tear near the upper fitment measuring 0.027 inches long.Visual examination under magnification noted a crush mark to the upper blue fitment.No other anomalies were observed.Functional testing and pressure testing confirmed a leak from the silicone tubing near the upper fitment.The cause of the reported leak was a tear in the silicone segment.The root cause of the tear is unknown.

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5564607
• MDR Text Key: 42235885
• Report Number: 9616066-2016-00493
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 62