MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR WITH INTEGRATED HEATEXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA #

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 12/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.

Event Description

According to the customer: change out from december 30th: lot=70124018.Change out time=~1min-> sat drop to 55% (from 90%) and pt became slightly.Hypotensive/bradycardic, but recovered within 3 mins of reinitiation of ecmo.Pt status= still on ecmo.Additional info: oxygenator was in use for 12 days prior to change out (this was this pts 2nd change out); (b)(6) yo m on vv ecmo for hypercapnic resp failure; there were some small clots formed on the pre membrane.Pre oxy- 7.38/73/33/42/62%.Post oxy- 7.43/62/183/40/98%.Primary reason for change out: thoracic surgery's decision based on pre/post marginal gases.Outcome: no big change in pt gases, but post po2 on new oxy was greatly improved (536 mmhg).Internal reference: (b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The returned oxygenator was investigated in the laboratory of the manufacturer.A quadrox-id adult with tubes and a foreign centrifugal was sent back.The complete set was heavily clotted.Tubes were removed and disposed of.Clots can be confirmed.The oxygenator was with a foreign centrifugal pump applied.Since the oxygenator is not leaking, is a tightness test is not necessary.Oxygenator and the foreign centrifugal pump was cleaned several times with sodium hypochlorite purified.To ensure performance of the products prior to shipment, checks, controls, and performance tests are carried out during the manufacture of the products.These tests can be reviewed as part of a dhr review.Dhr review result: affected product: 70106.7859 beq-hmod70000-usa #squadrox-id ad.O.Fil basic lot 70124017 and packaging lot 70124018 ( udi number (b)(4)).The avz from avp420 to avp434 (dms#2559809) was reviewed on (b)(6)2019.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed (dms#2573979), the performance tests passed the acceptance criteria thus the failure could not be confirmed based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.

• Brand Name: OXYGENATOR WITH INTEGRATED HEATEXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8286231
• MDR Text Key: 136855608
• Report Number: 8010762-2019-00019
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Model Number: BEQ-HMOD70000-USA #
• Device Catalogue Number: 701067859
• Device Lot Number: 70124018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention