MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested for evaluation; but not yet received.The investigation is pending.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): (b)(4).

Event Description

Customer changed out a hls 7.0 for abrupt gas exchange drop.There was no patient impact from change out.The patient was on for 72 hours, ptt 45-60.There was a small visible clot.(b)(4).

Manufacturer Narrative

The device was received at maquet cardiopulmonary (b)(4) for evaluation on the 2016-03-16.The complaints laboratory performed a visual inspection of the device and found the device to be severely damaged.Cleaning the device with sodium hypochlorite was not possible and therefore the device could not be further investigated.A dhr review of the lot was performed.The investigation found no abnormalities and all the controls were completed in accordance to the process control form.A search of the complaint handling database was also carried out on 2017-03-09 and (b)(4) other complaints were found, for which no product malfunction was found on investigation.The results indicate that there is not currently a systemic issue for the customer's reported problem.The damage most likely occurred in transit while returning the product to the factory.Based on the available information, a root cause cannot be determined.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and if a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Consequently, no further investigation or action is warranted at this time and the complaint will be closed.This is the final report.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, 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: 5450606
• MDR Text Key: 39232936
• Report Number: 8010762-2016-00098
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 5050 USA
• Device Catalogue Number: 701052797
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1