MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL CDU; APPARATUS, AUTOTRANSFUSION

Model Number 8888571299

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but at this time has not yet been received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports that when connected, the suction is working in reverse.

• Brand Name: AQUA-SEAL CDU
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086173640
• MDR Report Key: 8516169
• MDR Text Key: 142057374
• Report Number: 9611018-2019-00309
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 17J088FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1