MAUDE Adverse Event Report: CARDINAL HEALTH ARGYLE ALTITUDE DRY SUCT C D U; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571370
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the patient was with a chest tube since (b)(6) 2022 due to the presence of hemothorax.They were admitted to the intermediate care unit on (b)(6) 2022 and on (b)(6) 2022 drainage was observed in the water seal chamber and rest of the drainage in all the collecting chambers without the first one being full.In rounds, the doctor reports the finding and that the medical device has not fallen, so a chest tomography is performed and evidence of coagulated hemothorax requiring surgical intervention the next day to perform drainage.
Additional Manufacturer Narrative
(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One photo was provided for the investigation, but no physical sample was received.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported condition or determine if the device caused or contributed to the event.We also cannot determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.While the complaint indicates that the device did not fall, from the review of the photo there seems to be some fluid caught in the top of the vessel.The manufacturing site tried to recreate the fault and the only way that fluid could get up into that section is to turn the vessel on its side or upside down.At this time, there is not enough information, and a corrective and preventative action (capa) will not be initiated.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: ARGYLE ALTITUDE DRY SUCT C D U
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15365364
• Report Number: 9611018-2022-00562
• Device Sequence Number: 15185396
• Product Code: GCX
• UDI-Device Identifier: 10884521060975
• UDI-Public: 10884521060975
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 21K187FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown