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

Model Number MX9128

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

The customer the iv tubing was clamped off after it was noticed that the patient received 900 ml of fluids.During transport to the recovery room, the roller clamp opened up completely and was subsequently re-clamped.While giving report to charge staff, the roller clamp opened itself yet again prior to the iv being removed from the patient.It was reported that the patient received approximately 400 cc ¿extra¿ of fluid¿ (ringers lactate).No patient harm reported.

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Manufacturer Narrative

The customer¿s report of roller clamp not staying closed was not confirmed.Visual inspection of the set, especially the roller clamp component, noted no damages or any anomalies.No issues were also noted with the tubing in which the roller clamp ran along.Functional testing was performed and no leaking was observed.Dimensional analysis of the roller clamp housing and wheel was performed; and the components were within specification.The root cause of the customer¿s report was not identified.

Manufacturer Narrative

Correction: initial reporter address.

• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 4708082
• MDR Text Key: 5726960
• Report Number: 9616066-2015-00510
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9128
• Device Catalogue Number: MX9128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• 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