MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 352U5805

Device Problems Misassembled (1398); Appropriate Term/Code Not Available (3191)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the pediatric patients had been brought in to the intensive care unit with hypoxia and hypercarbia.The physician stated that the filter and vent circuits that were being used was not the correct sizes.It was indicated that they are using a filter adult/pediatrics large for all populations.

Manufacturer Narrative

Evaluation summary: without a sample it is not possible to define the causes of the problem occurred to the customer.One highlight is that this filter must not be used on patients having a tidal volume (vt) lower than those indicated in the table, as reported on the instructions for use (ifu).The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure of the observed condition to the filter.No new formal investigation is required, the event will be included in trending and monitoring.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DAR
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 9313479
• MDR Text Key: 166127865
• Report Number: 2936999-2019-00937
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 20884522037454
• UDI-Public: 20884522037454
• Combination Product (y/n): N
• PMA/PMN Number: K941381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352U5805
• Device Catalogue Number: 352U5805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other