MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number B0-HQV 67302

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested for investigation.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer:'ctp including in quadrox-i was primed according to instruction in quadrox-i ifu.Perfusion was started normally.Midway of the perfusion a leakage from the big luer connection in the middle of the quadrox arterial filter was noticed.Leakage was not heavy, so the quardox/ctp was not changed.The same incident happened in 2 cases with same lot.' (b)(4).

Manufacturer Narrative

(b)(4).The sample was unavailable for return as it had been discarded by the customer.Based on the trending for material number 70107.0505, a systemic issue is not indicated.However, maquet is aware of other similar complaints related to an issue of blood leakage from the dialysis lock connector and these were investigated in capa (b)(4).The lot of this complaint was manufactured after the last capa action which was completed on (b)(4).In response to a re-occurrence of a similar issue seen in customer complaints; (b)(4).Has been initiated to investigate.These complaints were all investigated in the laboratory and the root cause determined for each complaint was found to be leakage caused by offset at the o-ring.Based on these findings, a systemic issue can be determined and therefore, it can be concluded that the probable root cause for this complaint is also due to an offset at the o-ring.However, since it is not possible to investigate any further in this particular case, as the affected part has been discarded, the exact root cause for the reported failure cannot be established; therefore it is not possible to reliably associate this failure to the issue being investigated in capa (b)(4).No further investigation or action is currently warranted in addition to continued periodic monitoring and the complaint will be closed.

Event Description

Ref.: (b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 6083065
• MDR Text Key: 59796163
• Report Number: 8010762-2016-00659
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

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: 06/15/2018
• Device Model Number: B0-HQV 67302
• Device Catalogue Number: 701070505
• Device Lot Number: 92194640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: 10/05/2016
• Supplement Dates FDA Received: 09/14/2017
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1