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

Model Number	10012283
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Concomitant medical products: picc line (1.9 and 1.2 fr); 24 gauge iv catheters.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
It was reported that tpn(250ml) leaks around the filter.The customer stated that; "the nicu neonates have either picc or iv lines that are mate to tpn tubing to a trifuse for 20% intralipids and antibiotics infusions.The tpn rates varied from 5-12 ml/hr".The rn stated: "tubing was primed and hung/primed on september 30th and was noted to be leaking from the tpn filter on 10/2.There was no obvious signs of harm to the patient however a potential risk of infection".Although requested, no further details were provided by the customer for this event.
Additional Manufacturer Narrative
The customer¿s report of tpn leaks around the filter was confirmed.Functional testing observed leaking out of both filter vents on the set¿s micron filter.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed no damage to the filter¿s membrane or housing.Yellowish colored liquid was observed in the set¿s burette and entire length of tubing.Yellowish/brown colored dry material was observed on the outside of the entire set.Orange alcohol disinfecting caps were attached to all three of the set¿s smartsites.No abnormalities were observed on the set during visual inspection.To prepare the set for functional testing a picc line was attached to the set¿s male luer to simulate the customer¿s use description.The root cause of the leak was not identified.
Event or Problem Description
It was reported that tpn (250ml) leaks around the filter.The customer stated that the nicu neonates have either picc or iv lines that are mate to tpn tubing to a trifuse for 20% intralipids and antibiotics infusions.The tpn rates varied from 5-12 ml/hr.The rn stated tubing was primed and hung/primed on september 30th and was noted to be leaking from the tpn filter on10/2.There was no obvious signs of harm to the patient, however; there is a potential risk of infection.Although requested, no further details were provided by the customer for 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: 9279877
• Report Number: 9616066-2019-03062
• Device Sequence Number: 19533339
• Product Code: FPA
• UDI-Device Identifier: 10885403233692
• UDI-Public: 10885403233692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 03/02/2021
• Device Model Number: 10012283
• Device Catalogue Number: 10012283
• Device Lot Number: 18035035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: ORANGE ALCOHOL DISINFECTING CAPS; PRI TUBING, 20038E,(2) 8100, 8015, TD (B)(6) 2019