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

Model Number C24103E

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

Patient Problem No Code Available (3191)

Event Date 08/26/2018

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that the tubing broke off at a connection point and dripped blood while it was connected to a patient for no more than 24 hours.The patient experienced a small amount of blood loss as the line backed up onto the patient's bed.The patient was already receiving daily blood work.The blood work was done 6 hours earlier than its usual time.(b)(6) 06:55 am hgb: 92, (b)(6) 00:23 am hgb: 88.There was no written indication in the patient's chart that this drop in hgb was from the blood loss due to the line disconnection.The tubing was replaced and no lasting harm was reported.

Manufacturer Narrative

(disregard lot number).

Event Description

The customer reported that the tubing broke off at a connection point and dripped blood while it was connected to a patient for no more than 24 hours.The patient experienced a small amount of blood loss as the line backed up onto the patient's bed.The patient was already receiving daily blood work.The blood work was done 6 hours earlier than its usual time.(b)(6) 06:55 am hgb: 92, (b)(6) 00:23 am hgb: 88.There was no written indication in the patient's chart that this drop in hgb was from the blood loss due to the line disconnection.The tubing was replaced and no lasting harm was reported.

Event Description

The customer reported that the tubing broke off at a connection point and dripped blood while it was connected to a patient for no more than 24 hours.The patient experienced a small amount of blood loss as the line backed up onto the patient's bed.The patient was already receiving daily blood work.The blood work was done 6 hours earlier than its usual time.(b)(6) 06:55 am hgb: 92, (b)(6) 00:23 am hgb: 88.There was no written indication in the patient's chart that this drop in hgb was from the blood loss due to the line disconnection.The tubing was replaced and no lasting harm was reported.

• 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: 7894438
• MDR Text Key: 120887945
• Report Number: 9616066-2018-01774
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021371
• UDI-Public: 7613203021371
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: C24103E
• Device Catalogue Number: C24103E
• Device Lot Number: 17108296
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HSC# 62950, THERAPY DATE (B)(6) 2018; HSC# 62950, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Other