MAUDE Adverse Event Report: CAREFUSION ALARIS BLOOD INFUSION SET; BLOOD SET

Model Number 2477-0007

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

Continued from report resource: quality and regulatory affairs.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient' demographics requested, but was not received.

Event Description

It was reported that the spike of the iv infusion set adhered to the plastic of the bag and did not allow the platelets to infuse.The patient was on fluid restriction and since the platelets did not infuse, the patient received an additional 200ml of ns and required lasix to remove the excess fluid.There was no patient impact.

Event Description

It was reported that the spike was too small and short, which adhered to the platelets bag preventing it from being transfused.Since the platelets were not transfused, the patient needed to receive 200ml of normal saline and required administration of lasix to remove the excess fluid.

Manufacturer Narrative

Correction on initial report: b.1, e.2, e.3, g.3 & h.1 additional information provided: b.2 & b.5 no product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

• Brand Name: ALARIS BLOOD INFUSION SET
• Type of Device: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9659683
• MDR Text Key: 178137000
• Report Number: 9616066-2020-00270
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: 7613203019460
• Combination Product (y/n): N
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• Device Lot Number: 19075521
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other