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

Model Number 10010454

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): icu medical trifuse, therapy date (b)(6)2017.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.

Event Description

The customer reported that the tpn line was connected to a trifuse extension set and infusing at an unspecified rate thru a picc line.Approximately 10 hours later the line was found disconnected and leaking in the bed.The patient's blood sugar decreased to 40, the physician was notified and the patient was given additional unspecified fluids.A follow up blood sugar was drawn with a result of 94.It was reported by the nurse that it is uncertain if the disconnect occurred by not securing the line.Other separate infusions included lipids and a med line.The event occurred in the nicu.

Manufacturer Narrative

The customer¿s report of the tpn line disconnecting from the trifuse and leaking was not confirmed.The set was visually inspected including use of magnification and no issues were observed.Functional and pressure testing resulted in fluid flowing freely with no leaking or disconnection issues.Dimensional testing was performed and the measurements were within specification.The root cause of the customer¿s report of disconnection was not identified.The customer's mating trifuse was not received for investigation.

Event Description

The tpn rate was 23.3 ml/hr.The catheter was a 1.9 french catheter picc line which had been in use for 42 days.

• 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
• 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: 6821796
• MDR Text Key: 83688586
• Report Number: 9616066-2017-01226
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10010454
• Device Catalogue Number: 10010454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: (2)8100,8015,PRI TUBING,PICC LINE, TD (B)(6)2017
• Patient Outcome(s): Required Intervention