MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA#HL

Device Problem Misassembled (1398)

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

Event Date 01/08/2019

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 customer: they claim the pump is pulling from the arterial cannula and returning to the venous cannula.When i asked if the tubing was installed to the wrong cannulas they said they were installed correctly.They also claim that the pump was reading a negative flow for a bit.When asked if they are on zero flow mode they said no, flowmeter was installed in the correct direction of flow, and global override was not active.When asked if they could go on and try to increase the rpms to overcome potential backflow they did not feel that would help.Dr.(b)(6) would like us to send this disposable back for investigation.He feels that the pump within the housing is install backwards.I told them to quarantine the disposable and await instruction.They plan to prime a new set and try again.Internal reference: (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 (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).Maquet cardiopulmonary gmbh requested the product for investigation in the laboratory.The product was returned but was not investigated in the complaints lab because the device may contain biological residue of who risk group 3 and 4 considered to be infectious such as hiv, hepatitis a or b.(see attachment investigation summary report).Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.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.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.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8261290
• MDR Text Key: 133852133
• Report Number: 8010762-2019-00012
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Model Number: BEQ-HLS 5050 USA#HL
• Device Catalogue Number: 701052797
• Device Lot Number: 70122101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention