MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PAL 1523#BE-HLS

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet.Maquet cardiopulmonary (b)(4) will submit a supplemental medwatch on receipt of further information.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: blood leaking during ecmo therapy.(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 gmbh has requested the product for manufacturer investigation.However,we were informed that the product was not available.Based on the received complaint picture, it is clearly seen that the sample was cracked.Also, maquet gmbh is aware of similar complaint which was registered as #(b)(4).According to laboratory investigation results of (b)(4) ; claimed part was investigated.There was no screw cap of the luer lock on the connector.Several cracks on the luer lock of the 3/8x3/8 connector were detected.Leak test could not be carried out because it led to leakage through the cracks.No further abnormalities could be detected.The failure was confirmed by the laboratory.Getinge cp antalya has been evaluated the production steps of the set.The most probable cause of the failure is found as mounting failure caused by operator.Based on this failure could be confirmed.Sap trend search was performed (material 70104.7285, failure code crack fracture) which came to following results: 0 additional complaint was recorded which appears reported issues are the same since the last 12 months.Sap trend search was also performed based on similar failure code and same product group.Additionally 2 similar complaints were found.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,04%, which is below 1%.Due to this information no systemic issue could be determined.As a corrective action the operators were already trained about the same failure which was registered as(b)(4).The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigations will be completed as this time.

Event Description

Ref.: #(b)(4), cust.Ref.:(b)(4).

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8148026
• MDR Text Key: 129910347
• Report Number: 8010762-2018-00322
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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 Expiration Date: 09/08/2019
• Device Model Number: BE-PAL 1523#BE-HLS
• Device Catalogue Number: 70104.7285
• Device Lot Number: 92228965
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1