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

Model Number HMO 30000-J

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During lab investigation of complaint (b)(4) just during cleaning process of the product the blood inlet connector was fallen off.Based on this the failure could be confirmed.This additional complaint was opened in order to track and trend this observation.Trend search: a trend search was performed for p/n 70106.3733 failure code 0402 inlet connector no additional complaint was found.Beside of this the trend search was expanded to only failure code 0402 inlet connector fallen off and no additional complaint was found.Due to this information no systemic issue could be determined.No evidence was provided that this failure was noticed within the initial complaint report.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.The failure was determined to be the first of its kind and is being handled through a designated maquet cardiopulmonary trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation.Due to this no further action will be completed at this time.

Event Description

During cleaning process of the product in the laboratory of the manufacture the blood inlet connector was fallen off.This was detected during investigation of complaint # (b)(4).This additional complaint was opened in order to track and trend this observation.(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: 6148618
• MDR Text Key: 62188062
• Report Number: 8010762-2016-00708
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: HMO 30000-J
• Device Catalogue Number: 701063733
• Device Lot Number: 70105983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1