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

Model Number	10012283
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concomitant product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
It was reported that the tpn (250ml) filter leaked around the 2 areas on the back of the filter.Yesterday, a parent complained of being able to smell the tpn in her baby¿s bed and she was concerned that the filter was leaking.¿ the nurse opened a sterile 2x2 package and placed the filter inside the package and folded over the paper of the package.She rechecked it after an hour but there was no leak.The rn transferred the baby out of the bed for the mother to hold and shortly the tpn tubing leaked from the filter.The customer stated: ¿if you position the filter with the back side up and level eventually you will have 2 distinct drops of fluid around this area a note attached to product that stated: "this was on a picc 19 fr.Leaking tpn filter.I don't have lot for this tubing.Tubing changed on 10/11 at 0400 on 10/12 confirmed filter leaking.Filter leaking from area around the 2 round disks on the back side.The leak was small does not pour out.If you position filter with the back side up and level eventually you will have 2 distinct drops of fluid around those areas.
Additional Manufacturer Narrative
The customer¿s report of the tpn (250ml) filter leaked around the (2) areas on the back of the filter was confirmed and replicated on extension set model 20127e.Set model 10012283 was not received from the customer for inspection and testing.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Yellowish colored liquid was observed in the set¿s filter and entire length of tubing.An orange alcohol disinfecting cap was attached to the set¿s smartsite.No abnormalities were observed on the set during visual inspection.Functional testing observed leaking out of both filter vents on the set¿s micron filter on extension set model 20127e, and visual inspection observed no damage to the filter¿s membrane or housing.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leaking was due to a clog and/or oversaturation of filter and the time of use from which the fluid flow was restricted.The fluid then seeks the path of least resistance through the filter vent.
Event or Problem Description
It was reported that the tpn (250ml) filter leaked around the 2 areas on the back of the filter.Yesterday, a parent complained of being able to smell the tpn in her baby¿s bed and she was concerned that the filter was leaking.¿ the nurse opened a sterile 2x2 package and placed the filter inside the package and folded over the paper of the package.She rechecked it after an hour but there was no leak.The rn transferred the baby out of the bed for the mother to hold and shortly the tpn tubing leaked from the filter.The customer stated: ¿if you position the filter with the back side up and level eventually you will have 2 distinct drops of fluid around this area.

• 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: 9298483
• Report Number: 9616066-2019-03160
• Device Sequence Number: 19423167
• 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): 10/16/2019

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: 10012283
• Device Catalogue Number: 10012283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: 20127E,PICC LINE ORANGE CAP TRIFUSE,TD: (B)(6) 2019.