MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00703255

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Investigation by field service technician has been performed on 2018-03-22.According to service report it has been stated by the field safety technician: "during investigation, i placed known working pump on hl20 console without error.I placed sn (b)(4) on hl20 and began to turn dial to start rotation.I immediately got a "direction error".I was able to replicate this error several times.I was able to generate a "belt slip" error with extremely low rpm before the "direction error".I opened up unit and discovered the top belt had fallen off the top pulley.The bottom belt was still on pulley.Unit is being sent into repair depot for investigation.All further documentation will be provided by repair depot." thus the failure could be confirmed.Correction: 2018-04-02: service has been performed by repair depot.According to service report: replace damaged belts.Replace tacho strobe label because the damaged belts worn away the strobe marking on the label.Replace pm parts as required.Pm and functional test as per the service manual.All tests passed.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.

Event Description

Staff reported that after 7 hours on pump, an immediate high arterial pressure was measured, followed immediately by an audio alarm and pumping stopped on the rpm.Pump's power was recycled with same result.Alarm still present.Staff could not verify actual alarm.Staff clamped lines and started manual operation with emergency drive.Staff reports that turning emergency drive was extremely difficult.Excessive force had to be used to turn pump.Staff immediately reduced occlusion which resolved issue.Staff continued use with emergency drive until replacement pump was installed.No patient harm was reported.(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.(b)(4).Beside statement by the field service technician the belts have been returned to maquet laboratory (lce - life cycle engineering).According to investigation report, signed by lce on (b)(6) 2019, damaged belts (2 pc.) could be confirmed.One belt is heavily damaged.The trapezoid profile is broken in several places and the reinforcement fibers are partly torn.The probable root cause is a twisting of the belt due to a pre-existing defect, for example kinking during transport or deviations in the belt profile.The damage to the second belt is probably a consequential damage due to friction on the other damaged belt.Thus the failure could be confirmed.Most probable root cause could be determined as twisting of the belt due to a pre-existing defect, for example kinking during transport or deviations in the belt profile.

Event Description

Internal reference: (b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7425556
• MDR Text Key: 105531753
• Report Number: 8010762-2018-00132
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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 Model Number: MCP00703255
• Device Catalogue Number: 701028675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Device Age: YR
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 87