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

Model Number	11607704
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the tubing ballooned at the upper fitment of the pumping segment was confirmed by pressure testing.The balloon is caused by excessive pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No balloon observed silicone segment tubing (p/n 12088541) during inspection.Clear liquid was observed inside both of the set¿s tubing and drip chamber.No other anomalies were observed on the set during visual inspection.The set was loaded into a lab pump module device.The primary infusion was programmed at a rate of 100ml/h and vtbi 100ml for 1 hour.No alarms or any other issues were noted by the device.No bulge/ balloon was observed in the silicone segment.Finally the set was attached to an air pump and completely submerged in warm water.A balloon occurred at 17 psi.After the functional testing, three samples of the silicone segment were analyzed and the walls were found to be concentric.The customer¿s report that the set did not flow properly was not confirmed.Functional testing was performed and the set flowed properly.The root cause of the improper flow was not identified.
Event or Problem Description
It was reported during a potassium 30meq/normal saline 100ml at a rate of 100ml/hour that the tubing set developed a balloon in the silicone segment causing the iv infusion to not flow properly to the patient.The customer validated that there were no iv pushes administered prior to the balloon developing in the silicone segment.The customer further stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported during a potassium 30meq/normal saline 100ml at a rate of 100ml/hour that the tubing set developed a balloon in the silicone segment causing the iv infusion to not flow properly to the patient.The customer validated that there were no iv pushes administered prior to the balloon developing in the silicone segment.The customer further stated that there were no adverse effects caused to the patient from the event.Received a copy of the customer's medwatch report from fda which states, ¿iv pump tubing developed an outpouching (looks like a large bubble in the tubing) causing the iv fluids to not flow properly to the patient.Patient suffered no injury." the medwatch also stated that the event occurred in the critical care department.
Additional Manufacturer Narrative
Additional patient information: diagnosis; acute pancreatits; hypertension; morbidly obese; alcohol/drug use ethnicity: not hispanic/latino race: white medwatch stated patient weight: 145kg, customer reported patient weight as 137.7kg.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8895091
• Report Number: 9616066-2019-02294
• Device Sequence Number: 1400538
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 07/24/2019

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 Expiration Date: 04/04/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19045451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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, TD (B)(6) 2019
• Patient Age: 59 YR
• Patient Weight: 138