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

Model Number ROTAFLOW CONSOLE

Device Problem Loss of Power (1475)

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

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(4).Contact person- (b)(6).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 out: the customer stated that the unit shutdown while operating.During initial inspection the ac power switch was found to be turned off.The unit was running on battery power during previous operation and shutdown when battery power ran out.Per customer request the unit was also preventive maintained and the battery-pack ni-cd 24v 120wh (rfc) (material# (b)(4), serial# unknown) were replaced.The unit ran for 1.5 hours to verify no issues.The fst could not duplicated the initial problem.The unit was returned to customer and cleared for clinical use.According to the fst, it is unkown if the battery was due since we have not maintained the unit until now.Furthermore, the fst stated that the problem was a user error since the ac switch was turned off.Further investigation by our life cycle engineering (lce) is not possible since the battery is no longer available as it was disposed of by the customer.The most probable root cause could be determined as user error since the ac power switch was turned off.Thus the failure could not be confirmed.

Event Description

The customer stated that the unit shutdown while operating.During initial inspection the ac power switch was found to be turned off.The unit was running on battery power during previous operation and shutdown when battery power ran out.The unit was swapped out for another and treatment continued.No patient harm was reported.Internal reference: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7881478
• MDR Text Key: 120700136
• Report Number: 8010762-2018-00259
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: MCP00702697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention