MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has been requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: upon unpacking the quadrox the customer noticed the blood outlet connector was broken off. The packaging was not damaged. (b)(4).

Manufacturer Narrative

A beq-hmod30000-usa#quadrox-id pediatric oxygenator without filter was returned to the factory and an investigation was carried out in the decontamination / complaints laboratory. The product was inspected visually and it was found that the blood outlet connector was broken, consistent with the connector being subject to physical force or being damaged during transit. This is not a failure of the glue joint securing the blood outlet connector. Although an initial report was submitted for this issue, the investigation concludes that the issue does not constitute a reportable event, as the issue was detected upon opening the packaging, and therefore the product was excluded from any possible use on a patient. Note that as a result, no conclusion code has been entered, as no code was applicable for the reported issue.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6368475
• MDR Text Key: 69018930
• Report Number: 8010762-2017-00066
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/01/2018
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Device Lot Number: 70114600
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial