MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The field service technician (fst) was onsite for further investigation.According to the service report (b)(4), dated on (b)(6) 2018.Following was found: during the preventive mantenance the error message "comm" occured and it was intermittent.It errored, the fst turned off and the error went away for the rest of the day.The fst ordered a new board just in case and the next morning the error returned.The fst installed new flow measuring pcba (b)(4).Unit passed all calibration, functional and safety tests which were performed.Unit was returned to customer and cleared for clinical use.The old flow measuring pcba was requested with (b)(4) for return to (b)(4) for further investigation in our life cycle engineering.

Event Description

It was reported that during preventive maintenance the error message "comm" occurred intermittently.No patient involvement or harm.(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 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).Contact person- (b)(6).The old flow measuring pcba wasrequested with rma# (b)(4)for return to germany for further investigation in our life cycle engineering.According to the lce investigation# (b)(4) dated on 2018-11-26 following was found: the group-internal designation "measuring board rfc_fm or flow measurement board" is later referred to in the text as fmb and is managed in the erp system with the material number: 70103.7532 or spare part number: 70101.1681.Fmb has the serial number: (b)(4).The fmb did not show any abnormalities except for a badly soldered potentiometer connecting wire and was properly connected in an esd protected packaging delivered, but the esd bag and its contents were not between the two transport foam protection parts provided for this purpose.In order to be able to reproduce the fault which was complained, the supplied board has been built into an rfc.After switching on the rfc, the error message was displayed: def.Err displayed, but err com not displayed.This error could be corrected after the potentiometer has been soldered correctly to the board.The wire of the potentiometer was soldered on the wrong order.The wire was not first placed on the pad and then soldered, but solder was first placed on the pad and then the wire was pressed onto this spot.This can be seen very well by the hollow formation.The power-on test was repeated.When starting an rfc, the message "err com" can be displayed in the flow display for a few seconds immediately after acknowledgment of the "valve button", before the transmission of the flow values is initialized.A malfunction is only present if this message is displayed permanently or during operation.To prevent the service technician from receiving this message as an error, an attempt has been made to provoke the error.The fmb was then operated using an extension card outside the rfc.So that one could see whether heat development can trigger this error reproducibly, a heating air dryer was set to a temperature of 60°c and directed to the ic3 or m01.With a thermometer, a maximum temperature of 59.6 °c measured directly at the ic3 or mo1 was radiated onto the ic3 driver and the m01 processor.The error could not be provoked even after 10 minutes of exposure.Since heat/cold effects on the board can also lead to this error, the board was treated with cold spray at the above-mentioned points (driver and processor) until ice formation was visible on the component.To provoke or trigger the error directly, all communication lines were short-circuited to check if the lines are intact.The short-circuit test showed that all lines were intact (see table in investigation report).Short-circuiting the supply voltage led to the fmb's fuse f3 switched off.Since the error could not be reproduced, the error in the field is most probably were created sporadically.Thus the failure could not be confirmed.It was therefore not possible to determine the most probable cause of the error.The component cannot be released and reused since the error could not be uniquely localized.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7548563
• MDR Text Key: 109624787
• Report Number: 8010762-2018-00181
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 11/27/2018

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 Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1