MAUDE Adverse Event Report: SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ABC2707

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a solution set when used in conjunction with an unspecified infusion pump presented an alarm.The event was further described as "where it is mentioned that at the beginning of the infusion treatment to the patient, the clamp was inserted into the slot in the infusion pump, the programming of the infusion pump was started, the alarm went off immediately".The "air" alarm was noted and "they checked several times that the equipment had no air bubbles".The pump was changed four times and each one had the same outcome.The tubing was eventually changed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, and it was noted that an "air" alarm occurred during testing which suggested that the sample doesn't comply with the finished product specification.The reported condition was verified.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: SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12441071
• MDR Text Key: 270528526
• Report Number: 1416980-2021-05519
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412475356
• UDI-Public: (01)00085412475356
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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: Health Professional
• Device Catalogue Number: ABC2707
• Device Lot Number: 46BIE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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: UNSPECIFIED INFUSION PUMP