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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Device requested but not yet received.(b)(4).

Event Description

According to the customer: dr.(b)(6) reports a unacceptable reduction in oxygenation.A pao2 of 208 post oxygenation, and would like the disposable set investigated once removed from the patient.The customer changed out the set.No harm to the patient 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.Importer- (b)(4).The product was requested for return to the manufacturer for laboratory investigation.The returned product was investigated in the laboratory.An hls set was sent back.The set was contaminated.Tubes were removed and disposed of.Oxygenator was cleaned with sodium hypochlorite.The sample is strongly clotted.A further investigation is currently not possible for security reasons.Corresponding measures have already been initiated.Once these measures have been implemented, the investigation can be resumed.Failure could not be confirmed.Most probable root cause could not be determined at this time because further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.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.

Event Description

Internal reference: (b)(4).

• 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: 7538491
• MDR Text Key: 109491295
• Report Number: 8010762-2018-00179
• 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: 08/23/2018

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: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1