MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problem Output Problem (3005)

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

Event Date 11/01/2018

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 customer: an emergency patient requiring deep hypothermic circulatory arrest (dhca) was brought to theatre in the morning, and bypass commenced at 12:36.A patient core temp of 18c had been requested by the surgeon before dhca could be commenced.At approx.14:00 it was noted that patient temperature was not cooling past a core temp of 23.8c, and the outgoing temp registered by the machine was 16c (even when the set temp was as low as 8c).It was then noted that the ice block had melted.Patient temperature could not be lowered further and the decision was made to replace the hcu, mid surgery, to facilitate dhca.Additional information: the incident occurred during patient treatment.The patient condition is good as of today.(b)(4).

Event Description

Ref: (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).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer: (b)(4).Contact person: (b)(6).A field service technician was sent out for investigation.Technician downloaded the user events and service pool data.This was sent to factory for evaluation.Diagnostics was performed and all tests were passed.No failure was found.In 2016 a field safety corrective actions was release for hcu40.The fsca contained: revised cleaning and disinfection procedure, replacement of flow, 3-way and shunt valve, software update (old: 01.01.02, new: 01.01.03).However the customer refused to carry out this fsca.Life cycle engineering was asked to evaluate this case.The investigation is still ongoing.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

Ref.: (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)(6).The device was investigated by the life cycle engineer.Within the investigated data, no indication of a malfunction of the hcu was found.With a detailed investigation of the ice formation by a service technician an impaired cooling performance can be refuted definitely.It is recommended to operate the hcu with an increased ice setting when conducting surgeries with deep hypothermia.The software update does not correlate to the described incident.The low conductivity of the water could have affected the ice formation.This cannot be reproduced anymore.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.Since the failure is not reproducible the failure could not be confirmed.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.

Manufacturer Narrative

The dhr of the hcu40 (material: 70104.4054, serial: (b)(4)), was reviewed on (b)(6)2019.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.A field service technician tested the device according to the service protocol.All tests passed.Unit is ok to use.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.Maquet medical systems, usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).

Event Description

Ref.: (b)(4).Customer ref.: (b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8121344
• MDR Text Key: 129324514
• Report Number: 8010762-2018-00311
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1