MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY SET; SET, SECONDARY, INTRAVASCULAR

Model Number 11448964

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 0.9% normal saline and a bag of levofloxacin, therapy date (b)(6) 2018.No product will be returned as the anonymous customer could not be contacted.The root cause of this failure was not identified.

Event Description

Received a copy of the fda sus voluntary event report which states, "nurse reported that a new secondary tubing was primed with 0.9% normal saline and a bag of levofloxacin was spiked and initiated into the secondary tubing.The primary tubing was infusing with the normal saline.The nurse discovered sediment (precipitation), in the secondary drip chamber and the secondary line when levofloxacin was initiated.No precipitation was seen in the levofloxacin bag.The rn took down drug bag and tubing.A new bag of medication (same lot expiration) and secondary tubing (same lot and expiration) were used and the precipitation did not occur.Concomitant medical levofloxacin 750mg /150 ml mg milligram(s), mfr: claris life sciences, dc # (b)(4), lot # aob0183, exp: 01/31/2020, intravenous drip." there was no report of patient harm.The report lists product problem, but "other serious (important medical events)" is checked for adverse events.Since the reporter was anonymous no further information could be obtained regarding the "other serious" classification.

• Brand Name: ALARIS SECONDARY SET
• Type of Device: SET, SECONDARY, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7860054
• MDR Text Key: 119691197
• Report Number: 9616066-2018-01558
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: 18027055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRI TUBING, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Other