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

Model Number 2420-0500

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the bottom portion of the pump segment had detached from the tubing causing trastuzumab to leak.The medication squirted in the bed side nurse¿s eye, causing her to proceed with the hospitals protocol to wash her eyes and visit the er.There was no further reported injury to the nurse.

Manufacturer Narrative

The customer¿s report of tubing coming apart and leaked was confirmed.During visual inspection it was observed that the silicone segment was completely separated from the lower fitment.Dimensional testing was performed on the silicone segment tubing and fund to be within specification.Further visual inspection of the separated silicone segment end noted retainer ring indentations on the silicone segment showing that the retainer ring had been in place.Visual examination under microscope noted no crush mark to the upper or lower fitment.The ring retainer was not returned with the suspect set.The marking of the silicone segment from where the o-ring indentations separated from the lower fitment appeared to have a gap.Functional testing of the returned set was deemed unnecessary due to a separation in the silicone tubing.The separation of the silicone pumping segment to the lower fitment was caused by a gap at the engagement that allowed the separation to occur.The root cause of the gap and resulting separation is due to incorrect positioning of the components that was not detected by the sensor during assembly.

Event Description

It was reported that the bottom portion of the pump segment had detached from the tubing causing (trastuzumab) to leak.The medication squirted in the bed side nurse¿s eye, causing her to proceed with the hospitals protocol to wash her eyes and visit the er.There was no further reported injury to the nurse.

• 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: 9200211
• MDR Text Key: 162695115
• Report Number: 9616066-2019-02866
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• 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
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19076656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention