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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Coagulation Disorder (1779); Overdose (1988); Therapeutic Response, Increased (2272)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Although requested, no further information provided.No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the patient was on a heparin infusion for a provoked left basilic vein thrombus and was being transitioned to apixaban.The healthcare provider was stopping the heparin infusion, but forgot to clamp the tubing resulting in about 75% of a 25000 unit bag of heparin infusing into the patient.The patient had a stat aptt (prothrombin time) and anti-xa obtained and was pre-emptively given 50 mg of protamine.Although requested, no further information was provided.

Manufacturer Narrative

A review of the device history record showed the device had a manufacture date of 01/26/2007.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn 12475463 which did not confirm similar complaints with the same or related failure mode for this customer.The root cause for the reported issue that about 75% of a 25000 unit bag of heparin had infused into the patient was not determined because no product or device logs were returned.H3 other text : no product was returned.

Event Description

It was reported that the patient was on a heparin infusion for a provoked left basilic vein thrombus and was being transitioned to apixaban.The healthcare provider was stopping the heparin infusion, but forgot to clamp the tubing resulting in about 75% of a 25000 unit bag of heparin infusing into the patient.The patient had a stat aptt (prothrombin time) and anti-xa obtained and was pre-emptively given 50mg of protamine.Although requested, no further information was 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
• MDR Report Key: 11173200
• MDR Text Key: 227003620
• Report Number: 2016493-2021-09777
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, PRI TUBING, TD (B)(6) 2020
• Patient Outcome(s): Required Intervention