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

Model Number	C24103E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(disregard lot number).
Event or Problem 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7894438
• Report Number: 9616066-2018-01774
• Device Sequence Number: 1433789
• Product Code: FPA
• UDI-Device Identifier: 07613203021371
• UDI-Public: 7613203021371
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HSC# 62950, THERAPY DATE (B)(6) 2018; HSC# 62950, THERAPY DATE (B)(6) 2018
• Outcome Attributed to Adverse Event: Other