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

Model Number	11590100
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml b braun bag lot jnl125 exp 09/21, 10% dextrose &.20% nacl injection 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.Although requested, patient demographics was not provided.Patient is a neonate as the event occurred in neonatal intensive care unit.
Event or Problem Description
It was reported that the spike's tip broke off upon spiking the total parenteral nutrition (tpn) bag.The nurse discovered the issue as the part that broke off was seen bloating in the medication bag.There was a delay in infusion therapy due to changing of iv fluid.There was no patient harm.The event occurred in neonatal intensive care unit (nicu).
Additional Manufacturer Narrative
The customer¿s report that the spike's tip broke off upon spiking the bag was confirmed.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, kinks, holes, and tears in the tubing and its components.Visual inspection of the set noted the spike of the drip chamber was broken off near the tip of the spike.The broken spike tip piece was observed inside the bag.No other anomalies were observed on the drip chamber¿s spike or throughout the set.Examination under magnification of the spike¿s damaged surface found that the break site was rough and uneven with some plastic deformation.Rough/uneven surfaces with plastic deformation indicate a ductile fracture (vs.A brittle fracture characterized by a cleaner break and minimal plastic deformation) that is typically caused by an external lateral force.Functional testing was deemed unnecessary due to the drip chamber spike break.The breakage was caused by an external lateral force.The root cause of the external lateral force was not identified.
Event or Problem Description
It was reported that the spike's tip broke off upon spiking the total parenteral nutrition (tpn) bag.The nurse discovered the issue as the part that broke off was seen floating in the medication bag.There was a delay in infusion therapy due to changing of the iv fluid.The event occurred in the neonatal intensive care unit (nicu).Although it was noted that there was a delay in treatment, it was further confirmed during follow up, however; that there was no patient harm or impact as a result of this event.

• 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: 9787373
• Report Number: 9616066-2020-00662
• Device Sequence Number: 2778290
• Product Code: FPA
• UDI-Device Identifier: 10885403232411
• UDI-Public: 10885403232411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 11590100
• Device Catalogue Number: 11590100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: NON-BD EXT SET,(2)CUROS CAP,RED CAP, TD (B)(6) 2020