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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Noise, Audible (3273)

Patient Problem Hemolysis (1886)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.

Event Description

According to the customer: hls disposable pump made unusual noise while on patient.Customer switched out the device they said it was lysing the cells.No harm to the patient was reported.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 ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer: maquet medical systems usa.45 barbour pond drive.Wayne, nj 07470, contact person (b)(6).The returned hls module was investigated in the laboratory of the manufacturer on (b)(4).An visual inspection and a leak test according lv 201 on the hls module was performed.Also a circuit with the cardiohelp was performed.During the visual inspection blood under the pump cover was detected.Pump cover was removed and it was detected that the three of fours connections between the pump and the module was not mounted correctly.(screws are not tight enough).Also the seals are not placed correctly.This leads to a leak.During the tightness test a leak occurred on the connection between the pump and the module.For this detected leakage a separate complaint was open in sap (b)(4) in order to track and trend this observation.During the operation with the cardiophelp there are no abnormalities detected (no unusual noise pump was running with different rpm).Thus the failure could not be confirmed.As the reported failure could not be confirmed therefore to determined a root cause is not possible.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 GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8432613
• MDR Text Key: 142625008
• Report Number: 8010762-2019-00072
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention