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

Model Number	352U5805
Medical Device Problem Codes	Misassembled (1398); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2936999-2019-00937
• Device Sequence Number: 18972701
• Product Code: CAH
• UDI-Device Identifier: 20884522037454
• UDI-Public: 20884522037454
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K941381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 352U5805
• Device Catalogue Number: 352U5805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other