MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1008KP

Device Problem Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) large volume infusors had backflowed during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added: the device was manufactured from may 9, 2019 - may 10, 2019.One actual device was received and evaluated.The other device was not received and therefore, could not be evaluated.A visual inspection of the returned sample was performed using the naked eye which found evidence of leak/backflow at the fillport when the fillport cap was removed.Further inspection revealed the cause of the leak/backflow was due to a particle measured to be 0.70 square mm in size, lodged under the device checkband.The particle was subsequently identified to be acrylic material via ftir (fourier-transform infrared) spectroscopy test.Acrylic is the material of the device stressmember.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9841810
• MDR Text Key: 183720783
• Report Number: 1416980-2020-01470
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081359
• UDI-Public: (01)00085412081359
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1008KP
• Device Lot Number: 19E043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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