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

Model Number	10013361T
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag lot y300392 exp sep 20, doxorubicin (adriamucin) 16.4mg, etoposide (toposar) 82mg in sodium chloride 0.9%, 1000ml chemo infusion;10ml zr swabflush syringe lot 3136603 exp 2020-05-01 0.9% nacl injection; td 10/05/2019 the devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that the tubing set developed a "bubble" in the silicone segment while attached to a combined chemotherapy infusion bag of doxorubicin (adriamucin) 16.4m, etoposide (toposar) 82mg/sodium chloride 0.9%, 1000ml to infuse at a rate of 44.3ml/hour for a duration of 24 hours with a total vtbi of 1062.3ml.The customer further stated that there were no iv push medications administered prior to the balloon developing in the tubing set.The customer later stated that there were no adverse effects caused to the adult patient from the event.
Event or Problem Description
It was reported that the tubing set developed a "bubble" in the silicone segment while attached to a combined chemotherapy infusion bag of doxorubicin (adriamucin) 16.4m, etoposide (toposar) 82mg/sodium chloride 0.9%, 1000ml, to infuse at a rate of 44.3ml/hour for a duration of (24) hours, with a total vtbi of 1062.3ml.The customer further stated that there were no iv push medications administered prior to the "balloon" developing in the tubing set.The customer later stated that there were no adverse effects caused to the adult patient from this event.
Additional Manufacturer Narrative
The customer¿s report of a bulge in the silicone segment was confirmed by visual inspection of the as-received sample.Since the observation of the balloon in the silicone tubing segment has already been observed in a high number of previously investigated complaints, functional testing was not conducted.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection confirmed a balloon in the silicone pump segment near the upper fitment.The silicone pump segment was found to be within measurement specification(s) and the tubing was visually confirmed to be concentric.Previously investigated complaints for this failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

• 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: 9276513
• Report Number: 9616066-2019-03118
• Device Sequence Number: 2836674
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: 10885403223204
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 10013361T
• Device Catalogue Number: 10013361T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR