MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, BLOOD TRANSFUSION

Catalog Number FMC9682P

Device Problem Air Leak (1008)

Patient Problems Dyspnea (1816); Discomfort (2330); Shaking/Tremors (2515)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that small air bubbles (approx.1-2cm in size) were seen passing through the colleague infusion pump and accumulating in the tubing towards the patient in a clearlink vented blood administration set.It is unknown what medication was being infused.There were three medications being infused on three channels of the infusion pump.Premix kcl was running through channel a, cyclophosphamide through channel b, and mesna through channel c of the infusion pump.Customer states that patient experience discomfort and showed sign of shivering, cough, and breathlessness.Patient has already recovered.There is no report of patient/user injury or medical intervention was needed in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review will be performed.A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.This is the same event as (b)(4).

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A companion sample was returned for evaluation.Visual inspection was performed and the device was found to be within specifications.Dimension, gravity, and leak testing were performed with no issues noted.The reported condition could not be verified and the cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3629263
• MDR Text Key: 3990519
• Report Number: 1416980-2014-05424
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FMC9682P
• Device Lot Number: 13E03V334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: -CYCLOPHOSPHAMIDE; -MESNA.; -PREMIX KCL
• Patient Outcome(s): Other