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

Model Number	10933805
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 2 alcohol caps; one 250ml iv bag; the customer¿s reported that the tubing ballooned below where the tubing locks into the pump was confirmed.The root cause of the silicone segment balloon was not definitively determined.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.No other anomalies were observed on the set during visual inspection.Functional testing was performed by filling a lab iv bag with water and attaching it to the returned used disposable set.No issues were observed.During inspection it was observed that the silicone segment tubing had a balloon below the ring retainer of the upper fitment.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to bubble/ balloon.The root cause for the source of the excessive pressure is unknown.The customer¿s report that the pump was alarming for air in line followed by a safety clamp alarm was not confirmed.The device pump and pcu that were in use at the time of the customer event were not returned for investigation.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "noted air in line alarm followed by safety clamp alarm noted ballooning below first blue part where the tubing locks into the pump." an incomplete event date of (b)(6) 2019 was provided.The event occurred in the pediatric icu (picu).It was further confirmed during follow-up, that there was no patient harm as a result of this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9246116
• Report Number: 9616066-2019-02998
• Device Sequence Number: 3934688
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10933805
• Device Catalogue Number: 10933805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1