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

Model Number BEQ-HMOD 70000

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: the patient was being transported when the luer lock at the top of the arterial side broke off.The nurse clamped the line and put her finger over the hole.They were able to resume adequate flow.The patient was emergently switched to cardiohelp.The patient appears to be stable (as to her baseline pre-event).No harm to the patient was reported.(b)(4).

Manufacturer Narrative

The product was investigated in the manufacturer laboratory with the following outcome: a quadrox-id adult was sent back.The sample was contaminated.A luer lock on the blood outlet side has broken off.The broken luer lock with connection was not included.Cleaned with sodium hypochlorite.No further damage or abnormalities were found.A broken luer lock on the blood outlet side can be confirmed.No further damage or abnormalities were found.The most probable root cause could be the oblique termination edge suggesting a strong lateral mechanical action on the connector.Thus the failure could be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

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: 6921816
• MDR Text Key: 89717443
• Report Number: 8010762-2017-00324
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: BEQ-HMOD 70000
• Device Catalogue Number: 701053824
• Device Lot Number: 70110006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 09/30/2017
• Supplement Dates FDA Received: 12/13/2017
• Date Device Manufactured: 03/01/2016
• 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