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

Model Number HQV 9801

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: "according to the user: the oxygenator did not oxygenate" (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).Oxygenator was sent back for investigation in the laboratory of manufacturer.When rinsing the oxygenator with water, a clot (blood clot) was rinsed out on the blood outlet side.In the optical examination of the complaint pattern, no external damage was found.In the leak test according to lv 201, a leak was detected on the dialysis connector.As we are currently unable to open any complaints in the laboratory for safety-relevant reasons, the complaint sample will be stored in our archive and the examination of the mats and the dialysis connector will be made later.Since the full investigation could not performed at this moment, no sufficient information is available to confirm the failure.Once the further investigation is applicable, this complaint will be reopened.Sap trend search was performed according to the oxygenator batch.The products were found which 70112355 was used.No similar complaint was found which appears reported issues are the same since the last 12 months.Since the article number of the set is not available systemic issue calculation could not be performed.Based on this failure could not be confirmed.Device history record was reviewed.There were no references found which are indicating a nonconformance of the product in question.The data is 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

Ref.: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7549429
• MDR Text Key: 109625538
• Report Number: 8010762-2018-00188
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: HQV 9801
• Device Catalogue Number: 701035689
• Device Lot Number: 92194978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1