MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR,.F; SET, ADMINISTRATION, INFUSION

Model Number MZ9226

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2019

Event Type  malfunction  

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.Although requested, patient information was not provided.

Event Description

It was reported that five minutes after starting lasix infusion, the pump gave occlusion alarm.After assessing the tubing it was found that a small amount of fluid was leaking at filter.The tubing was changed and the medical team was notified.The event occurred in neonatal icu.There was no patient injury.Although requested, additional information was not provided.

Event Description

It was reported that five minutes after starting lasix infusion, the pump gave occlusion alarm.After assessing the tubing it was found that a small amount of fluid was leaking at filter.The tubing was changed and the medical team was notified.The event occurred in neonatal icu.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Although requested, additional event information was not provided.

Manufacturer Narrative

Additional information added; d10, & d11.The customer¿s report of a leak at the filter was confirmed based on visual inspection and functional testing.The set's micron filter's air vent membrane was wetted/compromised and a leak (termed ¿weeping out¿) was observed from the same area.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Functional testing was performed by pushing fluid through from the syringe.There was slight resistance observed during the push.The fluid was observed to exit the set's male luer end as expected and leak out from the filter vent.No other leak was observed.The root cause of the observed leak from the filter vent was not identified.The customer's other report that the pump gave an occlusion alarm was likely to have occurred due to the observed resistance during the fluid push.The root cause of the occlusion was not identified.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR,.F
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9536138
• MDR Text Key: 179420701
• Report Number: 9616066-2019-03802
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: 10885403240621
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ9226
• Device Catalogue Number: MZ9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10ML BD SYRINGE, ALCOHOL CAP; 8110,8015, THERAPY DATE 07/21/2019