MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HOLDER FOR VKMO/VHK 70000/7100; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HKH 7000

Device Problem Component Missing (2306)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 09:07 am (gmt-4:00) added by (b)(6) ((b)(4)): (b)(4) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Investigation of the actual device is pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the customer report: connected the oxygenator to the holder, however, it wasn't set well.It was found that the handle was missing on the lock part.No adverse effects on the patient." (b)(4).

Manufacturer Narrative

11/16/2015 04:51 pm (gmt-5:00) added by (b)(4)): a visual inspection was performed during laboratory investigation of the manufacturer.Thereby it was noticed, that two components of the holder have been missing.The eccentric clutch and the hinge bolt have been missing.Therefore the reported failure could be confirmed.A probable cause could be determined as an assembly error.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: HOLDER FOR VKMO/VHK 70000/7100
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5144123
• MDR Text Key: 28456163
• Report Number: 8010762-2015-01096
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HKH 7000
• Device Catalogue Number: 70106.4360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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