MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HQV 85500

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/12/2018

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:"initiated cpb,high ao line pressure and poor venous return.Terminated cpb,repositioned 10fr ao cannula,back on cpb,ao line pressures still high.Terminated cpb, upsized to 12fr ao cannula,back on cpb,ao line pressures still high.Off cpb again,upsized venous cannula to 16fr,back on cpb,high ao line pressures and venous return persisted.Consultant surgeon inspected patient's anatomy under direct vision; confirmed nothing untoward in patient's anatomy consistent with tetralogy of fallot presentation -no aortopulmonary collaterals and no left svc present.Patient's coagulation profile showed nothing of note, thromboelastograph normal;act before initiating cpb was >480sec.At this stage,cpb circuit was to be the issue,so cpb circuit was changed;cpb reinitiated using arterial and venous cannula already in situ.Normal ao line pressures and good venous return throughout.Post cpb,cpb circuit number 1 was flushed clear with saline solution.No particulate emboli or thrombus visible in circuit volume, saline flush volume or in cpb circuit components."(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- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).A quadrox-i neonatal and a vhk 11000 reservoir were returned.The sample was investigated visually.No further abnormalities were detected.A further investigation is currently not possible for safety reasons.Thus the reported failure could not be confirmed.Sap trend search was performed (search for material 70105.2272 and similar failure) which came to following result: no additional complaint was recorded since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4), which is below (b)(4).Due to this information no systemic issue could be determined.Affected product: basic lot 70119884 and packaging lot 70119919 (serial number (b)(4)).The avz from (b)(4) (dms# 2484733) was reviewed.There were no references found, which are indicating a nonconformance of the product.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.The most probable cause of the reported event remains unclear at this time.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

(b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7365558
• MDR Text Key: 103571283
• Report Number: 8010762-2018-00107
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 08/14/2018

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: 10/19/2019
• Device Model Number: HQV 85500
• Device Catalogue Number: 701052272
• Device Lot Number: 92239598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1