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

Catalog Number 2C1155KP

Device Problems No Flow (2991); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume multirate infusor did not flow.It was stated the device was probably occluded by air bubbles which resulted in no flow.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow was visually observed at the distal luer.A functional flow rate test was performed and the flow rate was found to be within the product specification range.The reported condition was not verified.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.

Manufacturer Narrative

Upon further investigation, it was determined that this report is a duplicate of manufacturers report # (b)(4).All investigation activities will be captured under mfg.Report # (b)(4).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
• MDR Report Key: 12268343
• MDR Text Key: 264804543
• Report Number: 1416980-2021-04746
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081403
• UDI-Public: (01)00085412081403
• Combination Product (y/n): Y
• PMA/PMN Number: K011317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

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: 2C1155KP
• Device Lot Number: 20A048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/09/2021; 08/20/2021
• Supplement Dates FDA Received: 08/19/2021; 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.