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

Model Number	10933805
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 2 alcohol caps; one used 1,000nl iv bag.The customer¿s report that the tubing ballooned and broke (separated) was confirmed as received.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, kinks, holes, and tears in the tubing and its components.During visual inspection it was observed that the silicone segment was separated from the upper fitment at the pump segment.No crush marks were observed on the upper or lower fitment.Functional testing was not performed due to leaking that would occur from the separated tubing.Further inspection found weakened tubing at the location where a balloon would naturally occur.This action was found to result in excessive pressure within the silicone segment causing the silicone segment to balloon and the silicone tubing to be stretched.The silicone pump tubing was found to be within measurement specifications.The root cause for the source of the excessive pressure is unknown.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "intravenous (iv) pump alarming occluded on patient side, when ruled out occlusion from patient and remains to alarm, iv pump opened noted tubing m pump forming balloon below blue portion of primary tubing and ruptured/broke." it was noted that iv potassium chloride in 5% dextrose and 0.9% sodium chloride was infusing at the time of the event.It was further confirmed during follow-up, that there was no patient harm as a result of this event.
Additional Manufacturer Narrative
The customer¿s report of that the tubing ballooned and broke (separated) was confirmed as received by visual inspection.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, kinks, holes, and tears in the tubing and its components.The silicone segment was separated from the upper fitment at the pump segment.No crush marks were observed on the upper or lower fitment.Further inspection of the top of the silicone tubing observed that a small portion of the silicone tubing was softened or weakened.The weakened tubing was also found to be at the location where a balloon would typically occur.The inner diameter of the silicone pump tubing was found to be within specification.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).The root cause was not identified.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "intravenous (iv) pump alarming occluded on patient side, when ruled out occlusion from patient and remains to alarm, iv pump opened noted tubing m pump forming balloon below blue portion of primary tubing and ruptured/broke." it was noted that iv potassium chloride in 5% dextrose and 0.9% sodium chloride was infusing at the time of the event.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: 9246788
• Report Number: 9616066-2019-03000
• Device Sequence Number: 409438
• 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: Risk Manager
• Type of Report: Initial,Followup
• 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015, THERAPY DATE (B)(6) 2019.