MAUDE Adverse Event Report: CAREFUSION SD ALARIS® PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problems Fail-Safe Problem (2936); Free or Unrestricted Flow (2945)

Patient Problem Visual Impairment (2138)

Event Date 10/27/2019

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.Although requested, patient identifier, race, and ethnicity was not provided.All available information has been provided.

Event Description

It was reported that the pump module alarmed that the door needed to be closed/clamped, so the nurse removed the tubing from the pump module and went obtain a different pump module.When the nurse returned, it was discovered that vancomycin had free flowed into the patient (who had been admitted to the hematology/oncology floor for a tumor removal).The free flow was not witnessed, but it's believed that the free flow occurred when the nurse removed the tubing from the alarming pump module.The patient complained of blindness for a few minutes which resolved on its own.The nurse noted the safety clamp was not engaged, and clinical engineering noted the pump module's sear was "completely broken off".

Event Description

It was reported that the pump module alarmed that the door needed to be closed/clamped, so the nurse removed the tubing from the pump module and went obtain a different pump module.When the nurse returned, it was discovered that vancomycin had free flowed into the patient (who had been admitted to the hematology/oncology floor for a tumor removal).The free flow was not witnessed, but it's believed that the free flow occurred when the nurse removed the tubing from the alarming pump module.The patient complained of blindness for a few minutes which resolved on its own.The nurse noted the safety clamp was not engaged, and clinical engineering noted the pump module's sear was "completely broken off.".

Manufacturer Narrative

Although requested, the affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.Although requested, patient identifier, race, and ethnicity was not provided.All available information has been provided.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9806401
• MDR Text Key: 188209403
• Report Number: 2016493-2020-00297
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8015,THERAPY DATE (B)(6) 2019
• Patient Outcome(s): Other
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 23 KG