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

Model Number 10062818

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

Patient Problem No Code Available (3191)

Event Date 02/07/2020

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.The requested information in patient demographics was not provided.Per customer, "unable to disclose due to patient confidentiality.".

Event Description

It was reported that during blood transfusion, the flow was running slowly.The nurse had to milk the tubing to help with the flow.However, the tubing came apart at the connection point.There was a delay in treatment as the blood transfusion had to be stopped and a new tubing needed to be set up.

Manufacturer Narrative

Additional information added to: d11 the customer¿s report that the blood tubing separated was confirmed.Further visual inspection of the separated silicone segment end noted o-ring indentations, indicating that the retainer ring had been properly assembled on the set.The silicone pump tubing was found to be within measurement specification.Functional testing could not be performed due to the set's separation.Blood fluid was observed to be noted from the separation.Visual inspection confirmed the set was separated at the pumping segment.The separation was at the engagement between the silicone pump segment tubing and the upper fitment.The ring retainer (p/n 601316-000) was not received with the set.No gaps on the silicone segment separation or any anomalies were noted during visual inspection.Functional testing could not be performed due to the set's separation and obvious leaking that would occur due to the separation.Device history record could not be performed on model 10062818 because the lot # for the suspect set was not provided.Although the root cause of the separation could not be definitively determined, at some point the set may have been pulled or stretched beyond the retention specification between the silicone segment and the set¿s upper fitment during use or set loading.

Event Description

It was reported that during blood transfusion, the flow was running slowly.The nurse had to milk the tubing to help with the flow.However, the tubing came apart at the connection point.There was a delay in treatment as the blood transfusion had to be stopped and a new tubing needed to be set up.

• Brand Name: ALARIS PUMP MODULE NON VENTED BLOOD SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9953111
• MDR Text Key: 193737013
• Report Number: 9616066-2020-01289
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: 7613203019668
• Combination Product (y/n): N
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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
• Device Operator: Health Professional
• Device Model Number: 10062818
• Device Catalogue Number: 10062818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100,THERAPY DATE (B)(6) 2020