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

Model Number 2434-0007

Device Problems Break (1069); Fluid/Blood Leak (1250); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, no additional information about the patient, medication, or event provided.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 Description

It was reported that in the newborn center, the nurse was troubleshooting an air in line alarm by flicking and stretching the pumping segment which resulted in the tubing breaking and leaked tpn.Although requested, no additional information about the event or patient demographics provided except there was no known patient harm.

Manufacturer Narrative

Patient was a neonate.The customer¿s report of that the tubing broke (separated) and leaked was confirmed.During visual inspection it was observed that the silicone segment (p/n 12088541) was completely separated from the upper fitment (p/n tc10008721).The ring retainer (p/n 601316-000) was received attached to the silicone tubing with the correct alignment.No crush marks were observed on the upper or lower fitment.The internal diameter of the silicone pump tubing was found to be within measurement specification.Functional testing showed no anomalies.The root cause of the customer¿s report was not identified.

Event Description

It was reported that in the newborn center, the nurse was troubleshooting an air in line alarm by flicking and stretching the pumping segment which resulted in the tubing breaking and leaked tpn.Although requested, no additional information about the event or patient demographics provided except there was no known patient harm.

Manufacturer Narrative

Correction:aware date for supplemental pr (b)(4).Correct aware date is (b)(4) 2019, not (b)(4) 2019.

Event Description

It was reported that in the newborn center, the nurse was troubleshooting an air in line alarm by flicking and stretching the pumping segment which resulted in the tubing breaking and leaked tpn.Although requested, no additional information about the event or patient demographics provided except there was no known patient harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8756213
• MDR Text Key: 149943457
• Report Number: 9616066-2019-01765
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: 7613203019682
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD (B)(6) 2019