MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXA/BAXTER REPEATER PUMP

Model Number 099

Device Problem Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  No Answer Provided  

Event Description

This report details an incident involving a baxa/baxter repeater pump.The repeater pump is a peristaltic pump for fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies.On (b)(4) 2014 baxter (b)(4) was informed of an event where the customer was using a bag of sterile water to reconstitute ingredients in a vial.The customer hung a bag that was not water and reconstituted an ingredient and delivered it to a patient.Attempts to obtain further details of the case ((b)(6) 2014) have been unsuccessful at this time; however, there was no report of patient injury or death.We are filing a mdr report because, if repeated, such an event could require intervention or contribute to a serious patient injury or possible death.If additional information regarding this event becomes available, a follow-up report will be submitted.

Manufacturer Narrative

Evaluation codes: method: no testing methods performed.There was no alleged defect or malfunction of the baxa/baxter device; therefore, there was no need for further device testing.Results: device performed according to specifications.Conclusions: no device failure.User error caused event summary: the investigation found that the cause of the event was due to an incorrect ingredient being used by the customer.There was no defect or malfunction of the repeater pump.No further action is required at this time.Should additional information regarding this event become available, a follow-up report will be submitted.

• Brand Name: BAXA/BAXTER REPEATER PUMP
• Type of Device: REPEATER PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 maroon circle; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: lou fearing ; 9540 maroon circle; englewood, CO 80112 ; 3037846653
• MDR Report Key: 4301884
• MDR Text Key: 5269803
• Report Number: 1419106-2014-00016
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 099
• Device Catalogue Number: 099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1