MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC9611G

Device Problem Cut In Material (2454)

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

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a solution administration set ¿split¿ while being removed from a baxter infusion pump after patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device and a companion sample were received for evaluation.Visual inspection on the actual sample identified that the tube was completely cut apart and was clipped in the slide clamp.The reported condition was verified.Visual inspection of the companion sample showed no issues.A pump functional test was performed on the companion sample received.Test passed as result was within the acceptance criteria.No issues were encountered when removing the set from the colleague pump.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the split tubing may be attributed either to misuse of product or a malfunction of the pump.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; malta
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6904365
• MDR Text Key: 87780646
• Report Number: 1416980-2017-07918
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMC9611G
• Device Lot Number: 17E19V478
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: COLLEAGUE INFUSION PUMP